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    Clinical Trial Results:
    Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Than 18 Years of Age With Confirmed or Suspected Gram-negative Bacterial Infection

    Summary
    EudraCT number
    		 2019-000338-20
    Trial protocol
    		 FR   PL   Outside EU/EEA   ES   BG   GR   NO   EE  
    Global end of trial date
    07 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2025
    First version publication date
    24 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-7655A-021
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03969901
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001809-PIP01-15
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 May 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to evaluate the safety and tolerability of imipenem/cilastatin/relebactam (IMI/REL) in participants from birth to less than 18 years of age with confirmed or suspected gram-negative bacterial infection. Participants are expected to require hospitalization through completion of intravenous (IV) study intervention, and have at least one of the following primary infection types: hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP); complicated intra-abdominal infection (cIAI); or complicated urinary tract infection (cUTI). Participants will be randomized in a 3:1 ratio to receive IMI/REL or active control. This study will also evaluate the efficacy of IMI/REL by assessing all-cause mortality at Day 28 post-randomization, as well as clinical and microbiological response to treatment. It will also evaluate the pharmacokinetics of IMI/REL.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Chile: 3
    Country: Number of subjects enrolled
    Colombia: 12
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Israel: 4
    Country: Number of subjects enrolled
    Mexico: 20
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Poland: 7
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    Türkiye: 11
    Country: Number of subjects enrolled
    Ukraine: 14
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    South Africa: 2
    Worldwide total number of subjects
    115
    EEA total number of subjects
    25
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    3
    Infants and toddlers (28 days-23 months)
    28
    Children (2-11 years)
    72
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All 15 of the nonrandomized participants who were screened but not enrolled were screen failures who either did not meet inclusion criteria or met exclusion criteria.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Age 12 to <18 years - IMI/REL
    Arm description
    		 Adolescents were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMI/REL (imipenem/cilastatin/relebactam)
    Investigational medicinal product code
    Other name
    MK-7655A
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMI 500 and REL 250 mg, IV infusion every 6 hours (q6h)

    Arm title
    		 Age 12 to <18 years– active control
    Arm description
    		 Adolescents were administered acceptable control option for each infection type via intravenous (IV) infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Active Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Acceptable control options for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.

    Arm title
    		 Age 6 to <12 years - IMI/REL
    Arm description
    		 Older children were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMI/REL (imipenem/cilastatin/relebactam)
    Investigational medicinal product code
    Other name
    MK-7655A
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours (q6h)

    Arm title
    		 Age 6 to <12 years - active control
    Arm description
    		 Older children were administered acceptable control option for each infection type via intravenous (IV) infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Active Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Acceptable control options for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.

    Arm title
    		 Age 2 to <6 years - IMI/REL
    Arm description
    		 Young children were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMI/REL (imipenem/cilastatin/relebactam)
    Investigational medicinal product code
    Other name
    MK-7655A
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours (q6h)

    Arm title
    		 Age 2 to <6 years - active control
    Arm description
    		 Younger children were administered acceptable control option for each infection type via intravenous (IV) infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Active Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Acceptable control options for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.

    Arm title
    		 Age 3 months to <2 years - IMI/REL
    Arm description
    		 Infants and toddlers were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMI/REL (imipenem/cilastatin/relebactam)
    Investigational medicinal product code
    Other name
    MK-7655A
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours (q6h)

    Arm title
    		 Age 3 months to <2 years- Active Control
    Arm description
    		 Infants and toddlers were administered acceptable control option for each infection type via intravenous (IV) infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Active Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Acceptable control options for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.

    Arm title
    		 Age Birth to <3 months: - IMI/REL
    Arm description
    		 Neonates and young infants were administered IMI/REL via intravenous (IV) infusion once every 8 hours (Q8W)
    Arm type
    		 Experimental

    Investigational medicinal product name
    IMI/REL (imipenem/cilastatin/relebactam)
    Investigational medicinal product code
    Other name
    MK-7655A
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IMI 15 and REL 7.5 mg/kg, IV infusion every 8 hours (q8h)

    Arm title
    		 Age Birth to <3 months - active control
    Arm description
    		 Neanates and young infants were administered acceptable control option for each infection type via intravenous (IV) infusion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Active Control
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Acceptable control options for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.

    Number of subjects in period 1
    		Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Started
    10
    2
    31
    11
    22
    8
    15
    5
    8
    3
    Treated
    10
    2
    31
    11
    21
    8
    15
    4
    8
    3
    Completed
    10
    2
    31
    11
    21
    8
    15
    4
    7
    3
    Not completed
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
         Withdrawal by parent/guardian
    -
    -
    -
    -
    1
    -
    -
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 115 115
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 3 3
        Infants and toddlers (28 days-23 months)
    		 28 28
        Children (2-11 years)
    		 72 72
        Adolescents (12-17 years)
    		 12 12
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender Categorical
    Units: Subjects
        Female
    		 56 56
        Male
    		 59 59
    Ethnicity
    NIH Categories for ethnicity
    Units: Subjects
        Hispanic or Latino
    		 43 43
        Not Hispanic or Latino
    		 70 70
        Unknown or Not Reported
    		 2 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 4 4
        Asian
    		 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 4 4
        White
    		 94 94
        Unknown or Not Reported
    		 0 0
        More than one race
    		 12 12
    Subject analysis sets

    Subject analysis set title
    All Participants Randomized- IMI/REL
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all participants across age cohorts randomized to IMI/REL at baseline

    Subject analysis set title
    All Participants Randomized- Active Control
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants across age cohorts randomized to active control at baseline

    Subject analysis sets values
    		 All Participants Randomized- IMI/REL All Participants Randomized- Active Control
    Number of subjects
    86
    29
    Age Categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    1
    2
        Infants and toddlers (28 days-23 months)
    22
    6
        Children (2-11 years)
    53
    19
        Adolescents (12-17 years)
    10
    2
        Adults (18-64 years)
    0
    0
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age Continuous
    Units:
        
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Female
    43
    13
        Male
    43
    16
    Ethnicity
    NIH Categories for ethnicity
    Units: Subjects
        Hispanic or Latino
    34
    9
        Not Hispanic or Latino
    50
    20
        Unknown or Not Reported
    2
    0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    3
    1
        Asian
    0
    1
        Native Hawaiian or Other Pacific Islander
    0
    0
        Black or African American
    3
    1
        White
    72
    22
        Unknown or Not Reported
    0
    0
        More than one race
    8
    4

    End points

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    End points reporting groups
    Reporting group title
    Age 12 to <18 years - IMI/REL
    Reporting group description
    		 Adolescents were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)

    Reporting group title
    Age 12 to <18 years– active control
    Reporting group description
    		 Adolescents were administered acceptable control option for each infection type via intravenous (IV) infusion

    Reporting group title
    Age 6 to <12 years - IMI/REL
    Reporting group description
    		 Older children were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)

    Reporting group title
    Age 6 to <12 years - active control
    Reporting group description
    		 Older children were administered acceptable control option for each infection type via intravenous (IV) infusion

    Reporting group title
    Age 2 to <6 years - IMI/REL
    Reporting group description
    		 Young children were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)

    Reporting group title
    Age 2 to <6 years - active control
    Reporting group description
    		 Younger children were administered acceptable control option for each infection type via intravenous (IV) infusion

    Reporting group title
    Age 3 months to <2 years - IMI/REL
    Reporting group description
    		 Infants and toddlers were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)

    Reporting group title
    Age 3 months to <2 years- Active Control
    Reporting group description
    		 Infants and toddlers were administered acceptable control option for each infection type via intravenous (IV) infusion

    Reporting group title
    Age Birth to <3 months: - IMI/REL
    Reporting group description
    		 Neonates and young infants were administered IMI/REL via intravenous (IV) infusion once every 8 hours (Q8W)

    Reporting group title
    Age Birth to <3 months - active control
    Reporting group description
    		 Neanates and young infants were administered acceptable control option for each infection type via intravenous (IV) infusion

    Subject analysis set title
    All Participants Randomized- IMI/REL
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all participants across age cohorts randomized to IMI/REL at baseline

    Subject analysis set title
    All Participants Randomized- Active Control
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants across age cohorts randomized to active control at baseline

    Primary: Percentage of Participants With One or More Adverse Events (AEs)

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    End point title
    		 Percentage of Participants With One or More Adverse Events (AEs) [1]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs is resented. The population analyzed includes all randomized participants who received at least one dose of IV study intervention.
    End point type
    Primary
    End point timeframe
    Up to approximately 28 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No official hypothesis testing was performed for this study.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    10
    2
    31
    11
    21
    8
    15
    4
    8
    2
    Units: Percentage
        number (not applicable)
    60.0
    50.0
    64.5
    36.4
    71.4
    62.5
    93.3
    50.0
    25.0
    66.7
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE)

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    End point title
    		 Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event (AE) [2]
    End point description
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants with AEs is resented. The population analyzed includes all randomized participants who received at least one dose of IV study intervention.
    End point type
    Primary
    End point timeframe
    Up to approximately 14 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No official hypothesis testing was performed for this study.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    10
    2
    31
    11
    21
    8
    14
    4
    8
    3
    Units: Subjects
        number (not applicable)
    0.0
    0.0
    12.9
    9.1
    0.0
    0.0
    6.74
    25.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Number of Deaths by All Causes Through Day 28

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    End point title
    		 Number of Deaths by All Causes Through Day 28
    End point description
    All-cause mortality up to 28 days post-randomization is presented. The population analyzed includes all randomized participants who received at least 1 dose of IV study intervention.
    End point type
    Secondary
    End point timeframe
    Up to Day 28
    End point values
    		 All Participants Randomized- IMI/REL All Participants Randomized- Active Control
    Number of subjects analysed
    85
    28
    Units: Participants
    0
    0
    Statistical analysis title
    		 Difference in Incidence of All-Cause Mortality
    Comparison groups
    All Participants Randomized- IMI/REL v All Participants Randomized- Active Control
    Number of subjects included in analysis
    113
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percent vs Active Control
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.2
         upper limit
    		 4.4

    Secondary: Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)

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    End point title
    		 Percentage of Participants With a Favorable Clinical Response at End of Therapy (EOT)
    End point description
    A favorable clinical response is defined as either "Cure"-All preintervention signs and symptoms of the index infection have resolved (or returned to “preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection, or "Improved" - The majority of preintervention signs and symptoms of the index infection have improved or resolved (or returned to “preinfection status", with no new symptoms) AND no additional antibacterial intervention is required. The population analyzed includes all randomized participants who received at least 1 dose of IV study intervention.
    End point type
    Secondary
    End point timeframe
    Day 5 up to Day 14
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    10
    2
    31
    11
    21
    8
    15
    4
    8
    3
    Units: Percentage of Participants
        number (confidence interval 95%)
    90 (57.4 to 100.0)
    50.0 (9.5 to 90.5)
    77.4 (59.9 to 88.9)
    81.8 (51.2 to 96.0)
    90.5 (69.9 to 98.6)
    87.5 (50.8 to 99.9)
    53.3 (30.1 to 75.2)
    75.0 (28.9 to 96.6)
    87.5 (50.8 to 99.9)
    33.3 (5.6 to 79.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Favorable Clinical Response at Early Follow-Up (EFU)

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    End point title
    		 Percentage of Participants with Favorable Clinical Response at Early Follow-Up (EFU)
    End point description
    A favorable clinical response at EFU requires an assessment of " Sustained Cure" -All preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) with no evidence of resurgence AND no additional antibacterial intervention is required for the index infection, or "Cure" - All preintervention signs and symptoms of the index infection have resolved (or returned to “preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection.
    End point type
    Secondary
    End point timeframe
    Day 12 up to Day 28
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    10
    2
    31
    11
    21
    8
    15
    4
    8
    3
    Units: Percentage of Participants
        number (confidence interval 95%)
    90.0 (57.4 to 100.0)
    50.0 (9.5 to 90.5)
    77.4 (59.9 to 88.9)
    81.8 (51.2 to 96.0)
    85.7 (64.5 to 95.9)
    87.5 (50.8 to 99.9)
    26.7 (10.5 to 52.4)
    75.0 (28.9 to 96.6)
    62.5 (30.4 to 86.5)
    33.3 (5.6 to 79.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU)

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    End point title
    		 Percentage of Participants With a Favorable Clinical Response at Late Follow-Up (LFU)
    End point description
    A favorable clinical response at EFU requires an assessment of " Sustained Cure" -All preintervention signs and symptoms of the index infection have resolved (or returned to "preinfection status", with no new symptoms) with no evidence of resurgence AND no additional antibacterial intervention is required for the index infection, or "Cure" - All preintervention signs and symptoms of the index infection have resolved (or returned to “preinfection status", with no new symptoms) AND no additional antibacterial intervention is required for the index infection.
    End point type
    Secondary
    End point timeframe
    Day 19 up to Day 42
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    10
    2
    31
    11
    21
    8
    15
    4
    8
    3
    Units: Percentage of Participants
        number (confidence interval 95%)
    90.0 (57.4 to 100.0)
    50.0 (9.5 to 90.5)
    74.2 (56.5 to 86.5)
    81.8 (51.2 to 96.0)
    81.0 (59.4 to 92.9)
    87.5 (50.8 to 99.9)
    33.3 (15.0 to 58.5)
    75.0 (28.9 to 96.6)
    62.5 (30.4 to 86.5)
    33.3 (5.6 to 79.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT)

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    End point title
    		 Percentage of Participants With a Favorable Microbiological Response at End of Therapy (EOT)
    End point description
    A favorable by-pathogen microbiological response at EOT requires “eradication” or “presumed eradication” of the pathogen found at study entry. The population analyzed included all randomized participants who met the following conditions: For participants with HABP/VABP and cIAI: The participant received at least 1 dose of IV study intervention; AND The participant’s baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: The participant received at least 1 dose of IV study intervention; AND The participant’s baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Day 5 up to Day 14
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    7
    2
    27
    10
    16
    5
    11
    4
    7
    2
    Units: Percentage of Participants
        number (confidence interval 95%)
    100.0 (59.6 to 100.0)
    100.0 (16.7 to 100.0)
    100.0 (85.2 to 100.0)
    100.0 (67.9 to 100.0)
    100.0 (77.3 to 100.0)
    100.0 (51.1 to 100.0)
    72.7 (42.9 to 90.8)
    75.0 (28.9 to 96.6)
    100.0 (59.6 to 100.0)
    50.0 (9.5 to 90.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU)

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    End point title
    		 Percentage of Participants With a Favorable Microbiological Response at End of Follow-Up (EFU)
    End point description
    A favorable by-pathogen microbiological response at the EFU visit requires “eradication” or “presumed eradication” of the pathogen found at study entry. The population analyzed included all randomized participants who met the following conditions: For participants with HABP/VABP and cIAI: The participant received at least 1 dose of IV study intervention; AND The participant’s baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: The participant received at least 1 dose of IV study intervention; AND The participant’s baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Day 12 up to Day 28
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    7
    1
    27
    10
    16
    5
    11
    4
    7
    2
    Units: Percentage of Participants
        number (confidence interval 95%)
    71.4 (35.2 to 92.4)
    100.0 (16.7 to 100.0)
    96.3 (80.2 to 100.0)
    100.0 (67.9 to 100.0)
    93.8 (69.7 to 100.0)
    100.0 (51.1 to 100.0)
    63.6 (35.2 to 85.0)
    75.0 (28.9 to 96.6)
    71.4 (35.2 to 92.4)
    50.0 (9.5 to 90.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU)

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    End point title
    		 Percentage of Participants With a Favorable Microbiological Response at Late Follow-Up (LFU)
    End point description
    A favorable by-pathogen microbiological response at the EFU visit requires “eradication” or “presumed eradication” of the pathogen found at study entry. The population analyzed included all randomized participants who met the following conditions: For participants with HABP/VABP and cIAI: The participant received at least 1 dose of IV study intervention; AND The participant’s baseline infection-site culture grew at least 1 gram-negative pathogenic organism. For participants with cUTI: The participant received at least 1 dose of IV study intervention; AND The participant’s baseline urine culture grew at least 1 gram-negative pathogenic organism at sufficient quantity (ie, growth at ≥105 CFU/mL of uropathogen). Participants were included in the intervention group to which they were randomized.
    End point type
    Secondary
    End point timeframe
    Day 19 up to Day 42
    End point values
    		 Age 12 to <18 years - IMI/REL Age 12 to <18 years– active control Age 6 to <12 years - IMI/REL Age 6 to <12 years - active control Age 2 to <6 years - IMI/REL Age 2 to <6 years - active control Age 3 months to <2 years - IMI/REL Age 3 months to <2 years- Active Control Age Birth to <3 months: - IMI/REL Age Birth to <3 months - active control
    Number of subjects analysed
    7
    1
    27
    10
    16
    5
    11
    4
    7
    2
    Units: Percentage of Participants
        number (confidence interval 95%)
    85.7 (46.7 to 99.5)
    0.0 (0.0 to 83.3)
    96.3 (80.2 to 100.0)
    100.0 (67.9 to 100.0)
    87.5 (62.7 to 97.8)
    100.0 (51.1 to 100.0)
    72.7 (42.9 to 90.8)
    75.0 (28.9 to 96.6)
    71.4 (35.2 to 92.4)
    50.0 (9.5 to 90.5)
    No statistical analyses for this end point

    Secondary: Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL

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    End point title
    		 Area Under the Curve From Time 0 to 24 Hours (AUC0-24) of Imipenem Following Administration of IMI/REL [3]
    End point description
    Blood samples were collected to determine the AUC0-24 of Imipenem. The population analyzed includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
    End point type
    Secondary
    End point timeframe
    On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in arms who received IMI/REL were included. Participants in arms who received active control were not included since they did not have imipenem measurements.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - IMI/REL Age 2 to <6 years - IMI/REL Age 3 months to <2 years - IMI/REL Age Birth to <3 months: - IMI/REL
    Number of subjects analysed
    10
    31
    21
    15
    8
    Units: µM/hr
        geometric mean (geometric coefficient of variation)
    610 ( 55.5 )
    720 ( 25.8 )
    692 ( 23.5 )
    788 ( 28.4 )
    795 ( 19.5 )
    No statistical analyses for this end point

    Secondary: AUC0-24 of Relebactam Following Administration of IMI/REL

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    End point title
    		 AUC0-24 of Relebactam Following Administration of IMI/REL [4]
    End point description
    Blood samples were collected to determine the AUC0-24 of relebactam. The population analyzed includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
    End point type
    Secondary
    End point timeframe
    On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, and 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or Day 3) at 2 to 6 hours after start of any infusion that day.
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in arms who received IMI/REL were included. Participants in arms who received active control were not included since they did not have relebactam measurements.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - IMI/REL Age 2 to <6 years - IMI/REL Age 3 months to <2 years - IMI/REL Age Birth to <3 months: - IMI/REL
    Number of subjects analysed
    10
    31
    21
    15
    8
    Units: µM/hr
        geometric mean (geometric coefficient of variation)
    399 ( 64 )
    469 ( 30.9 )
    459 ( 30.4 )
    634 ( 56.8 )
    605 ( 50.1 )
    No statistical analyses for this end point

    Secondary: Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL

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    End point title
    		 Concentration at End of Infusion (Ceoi) of Imipenem Following Administration of IMI/REL [5]
    End point description
    Blood samples were collected to determine the Ceoi of imipenem. The population analyzed includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
    End point type
    Secondary
    End point timeframe
    At the end of the first infusion on Day 1
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in arms who received IMI/REL were included. Participants in arms who received active control were not included since they did not have imipenem measurements.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - IMI/REL Age 2 to <6 years - IMI/REL Age 3 months to <2 years - IMI/REL Age Birth to <3 months: - IMI/REL
    Number of subjects analysed
    10
    31
    21
    15
    8
    Units: µM
        geometric mean (geometric coefficient of variation)
    79.2 ( 17.6 )
    103 ( 15 )
    101 ( 12.7 )
    109 ( 14.1 )
    117 ( 5.51 )
    No statistical analyses for this end point

    Secondary: Ceoi of Relabactam Following Administration of IMI/REL

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    End point title
    		 Ceoi of Relabactam Following Administration of IMI/REL [6]
    End point description
    Blood samples were collected to determine the Ceoi of relabactam . The population analyzed includes all participants who received at least 1 dose of IMI/REL and had at least one measurable pharmacokinetic (PK) sample.
    End point type
    Secondary
    End point timeframe
    At the end of the first infusion on Day 1.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in arms who received IMI/REL were included. Participants in arms who received active control were not included since they did not have relabactam measurements.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - IMI/REL Age 2 to <6 years - IMI/REL Age 3 months to <2 years - IMI/REL Age Birth to <3 months: - IMI/REL
    Number of subjects analysed
    10
    31
    21
    10
    8
    Units: µM
        geometric mean (geometric coefficient of variation)
    43.4 ( 28.6 )
    56.1 ( 18.6 )
    56.1 ( 16.2 )
    67.1 ( 27.4 )
    67.9 ( 22.2 )
    No statistical analyses for this end point

    Secondary: Percentage of Free Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%fT>MIC) of Imipenem Following Administration of IMI/REL

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    End point title
    		 Percentage of Free Time Imipenem Concentration Is Above Minimum Inhibitory Concentration (%fT>MIC) of Imipenem Following Administration of IMI/REL [7]
    End point description
    Blood samples were collected to determine the %fT>MIC of Imipenem. The population analyzed includes all participants who received at least 1 dose of IMI/REL, had at least one measurable PK sample, and had a baseline microbiological response.
    End point type
    Secondary
    End point timeframe
    On Day 1 at 30 minutes prior to start of first IV infusion of study drug, at end of first infusion, 2 to 6 hours after start of first infusion; and once at on-therapy visit (Day 2 or 3) at 2 to 6 hours after start of any infusion that day.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only participants in arms who received IMI/REL were included. Participants in arms who received active control were not included since they did not have imipenem measurements.
    End point values
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - IMI/REL Age 2 to <6 years - IMI/REL Age 3 months to <2 years - IMI/REL Age Birth to <3 months: - IMI/REL
    Number of subjects analysed
    6
    22
    15
    8
    6
    Units: Percentage
        arithmetic mean (standard deviation)
    100 ( 0 )
    93.4 ( 22.1 )
    83.6 ( 23.1 )
    79.6 ( 35.3 )
    83.5 ( 25.6 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 42 days
    Adverse event reporting additional description
    The populations analyzed includes all randomized participants who received at least 1 dose of study intervention. Participants were included in the intervention group corresponding to the study intervention they actually received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Age 12 to <18 years - IMI/REL
    Reporting group description
    		 Adolescents were administered IMI/REL via intravenous (IV) infusion once every 6 hours (Q6W)

    Reporting group title
    Age 6 to <12 years - active control
    Reporting group description
    		 Older children were administered acceptable control option for each infection type via IV infusion

    Reporting group title
    6 to <12 years - IMI/REL
    Reporting group description
    		 Older children were administered IMI/REL via iIV infusion Q6W

    Reporting group title
    Age 12 to <18 years – active control
    Reporting group description
    		 Adolescents were administered acceptable control option for each infection type via intravenous (IV) infusion

    Reporting group title
    Age Birth to <3 months - IMI/REL
    Reporting group description
    		 Neonates and young infants were administered IMI/REL via IV infusion Q8W

    Reporting group title
    Age 3 months to <2 years - active control
    Reporting group description
    		 Infants and toddlers were administered acceptable control option for each infection type via iIV infusion

    Reporting group title
    Age 3 months to <2 years- IMI/REL
    Reporting group description
    		 Infants and toddlers were administered IMI/REL via IV infusion Q6W

    Reporting group title
    Age 2 to <6 years - active control
    Reporting group description
    		 Younger children were administered acceptable control option for each infection type via iIV infusion

    Reporting group title
    Birth to <3 months - active control
    Reporting group description
    		 Neanates and young infants were administered acceptable control option for each infection type via IV infusion

    Reporting group title
    Age 2 to <6 years - IMI/REL
    Reporting group description
    		 Young children were administered IMI/REL via IV infusion Q6W

    Serious adverse events
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - active control 6 to <12 years - IMI/REL Age 12 to <18 years – active control Age Birth to <3 months - IMI/REL Age 3 months to <2 years - active control Age 3 months to <2 years- IMI/REL Age 2 to <6 years - active control Birth to <3 months - active control Age 2 to <6 years - IMI/REL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    6 / 31 (19.35%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    4 / 15 (26.67%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Drug intolerance
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    2 / 31 (6.45%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Short-bowel syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Age 12 to <18 years - IMI/REL Age 6 to <12 years - active control 6 to <12 years - IMI/REL Age 12 to <18 years – active control Age Birth to <3 months - IMI/REL Age 3 months to <2 years - active control Age 3 months to <2 years- IMI/REL Age 2 to <6 years - active control Birth to <3 months - active control Age 2 to <6 years - IMI/REL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    3 / 11 (27.27%)
    17 / 31 (54.84%)
    1 / 2 (50.00%)
    2 / 8 (25.00%)
    2 / 4 (50.00%)
    12 / 15 (80.00%)
    5 / 8 (62.50%)
    1 / 3 (33.33%)
    13 / 21 (61.90%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    General disorders and administration site conditions
    Infusion site phlebitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Thirst
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    2 / 31 (6.45%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    1
    2
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oedema
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Medical device site dermatitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vascular device occlusion
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Atelectasis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Laryngospasm
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    3 / 31 (9.68%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Creatinine urine decreased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    pH urine increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urobilinogen urine increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Urine uric acid increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 11 (0.00%)
    2 / 31 (6.45%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    3
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Neutropenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Thrombocytosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    2 / 31 (6.45%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    2
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    4 / 31 (12.90%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    0
    1
    0
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    4 / 31 (12.90%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    1
    4
    0
    1
    0
    0
    1
    0
    3
    Vomiting
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 11 (0.00%)
    5 / 31 (16.13%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    3 / 8 (37.50%)
    0 / 3 (0.00%)
    4 / 21 (19.05%)
         occurrences all number
    2
    0
    5
    0
    1
    0
    2
    5
    0
    5
    Nausea
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    5 / 31 (16.13%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    15
    0
    0
    0
    0
    1
    0
    0
    Ileus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dermatitis diaper
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    2 / 15 (13.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Urethral fistula
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Osteochondritis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Infections and infestations
    Otitis media
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    Device related infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Otitis media acute
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 4 (25.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pyuria
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 31 (3.23%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    0 / 15 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Hypervolaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 31 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 4 (0.00%)
    1 / 15 (6.67%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2019
    Amendment 02: Decreased the planned enrollment numbers (including overall, by age group, and by infection site).
    11 Jan 2022
    Amendment 03: Clarified the dosing regimen of MK-7655A for participants enrolled in Age Cohorts 3 months to <2 years, and neonates and young infants, based on the interim review of safety, tolerability, and pharmacokinetic data. The amendment also added piperacillin/tazobactam IV to the list of comparator medications allowed for participants with complicated intra-abdominal infection (cIAI).
    03 Nov 2022
    Amendment 04: Sponsor entity name and address change
    13 Sep 2023
    Amendment 05: Clarified the type of infection required for enrollment of participants aged birth to <3 months in the study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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