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    Clinical Trial Results:
    A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Subjects with Complicated Urinary Tract Infection, Including Pyelonephritis

    Summary
    EudraCT number
    		 2016-004153-32
    Trial protocol
    		 HU   PL   GR   Outside EU/EEA   RO  
    Global end of trial date
    20 Jan 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jul 2021
    First version publication date
    14 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    7625A-034
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03230838
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001142-PIP01-11
    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
    03 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with complicated urinary tract infection (cUTI), including pyelonephritis.
    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
    26 Apr 2018
    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
    Greece: 36
    Country: Number of subjects enrolled
    Hungary: 22
    Country: Number of subjects enrolled
    Mexico: 9
    Country: Number of subjects enrolled
    Poland: 17
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Turkey: 14
    Country: Number of subjects enrolled
    Ukraine: 22
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    134
    EEA total number of subjects
    75
    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)
    50
    Children (2-11 years)
    61
    Adolescents (12-17 years)
    20
    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
    		 Males and females from birth (>32 weeks gestational age and ≥7 days postnatal) to <18 years of age with complicated urinary tract infection (cUTI), including pyelonephritis, were enrolled in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ceftolozane/Tazobactam
    Arm description
    		 Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ceftolozane/Tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    12 to <18 years of age: Ceftolozane 1 g/dose; Tazobactam 0.5 g/dose via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days. <12 years of age: Ceftolozane 20 mg/kg with Tazobactam 10 mg/kg (not to exceed Ceftolozane 1 g and Tazobactam 0.5 g) via a 60-minute (±10 minutes) IV infusion every 8 hours for 7-14 days.

    Arm title
    		 Meropenem
    Arm description
    		 Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Meropenem 20 mg/kg to maximum 1 g/ dose every 8 hours for 7-14 days

    Number of subjects in period 1
    		Ceftolozane/Tazobactam Meropenem
    Started
    101
    33
    Treated
    100
    33
    Completed
    97
    33
    Not completed
    4
    0
         Consent withdrawn by subject
    3
    -
         Temperature excursion
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ceftolozane/Tazobactam
    Reporting group description
    		 Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days

    Reporting group title
    Meropenem
    Reporting group description
    		 Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days

    Reporting group values
    		 Ceftolozane/Tazobactam Meropenem Total
    Number of subjects
    		 101 33 134
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 2 1 3
        Infants and toddlers (28 days-23 months)
    		 38 12 50
        Children (2-11 years)
    		 46 15 61
        Adolescents (12-17 years)
    		 15 5 20
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 5.3 ( 5.3 ) 5.5 ( 5.7 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 65 20 85
        Male
    		 36 13 49
    Race
    Units: Subjects
        Asian
    		 1 0 1
        White
    		 100 33 133
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 9 5 14
        Not Hispanic Or Latino
    		 81 27 108
        Not Reported
    		 1 0 1
        Unknown
    		 10 1 11

    End points

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    End points reporting groups
    Reporting group title
    Ceftolozane/Tazobactam
    Reporting group description
    		 Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days

    Reporting group title
    Meropenem
    Reporting group description
    		 Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days

    Primary: Number of participants with ≥1 adverse events (AEs)

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    End point title
    		 Number of participants with ≥1 adverse events (AEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The population analyzed was all randomized participants who received any amount of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Day 88
    End point values
    		 Ceftolozane/Tazobactam Meropenem
    Number of subjects analysed
    100
    33
    Units: Participants
    59
    20
    Statistical analysis title
    		 Difference in Percentage (C/T minus Mero)
    Statistical analysis description
    The Miettinen & Nurminen method was used.
    Comparison groups
    Ceftolozane/Tazobactam v Meropenem
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.7
         upper limit
    		 17.9

    Primary: Number of participants discontinuing study therapy due to an AE

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    End point title
    		 Number of participants discontinuing study therapy due to an AE
    End point description
    An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The population analyzed was all randomized participants who received any amount of study treatment.
    End point type
    Primary
    End point timeframe
    Up to Day 15
    End point values
    		 Ceftolozane/Tazobactam Meropenem
    Number of subjects analysed
    100
    33
    Units: Participants
    1
    0
    Statistical analysis title
    		 Difference in Percentage (C/T minus Mero)
    Statistical analysis description
    The Miettinen & Nurminen method was used.
    Comparison groups
    Ceftolozane/Tazobactam v Meropenem
    Number of subjects included in analysis
    133
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.5
         upper limit
    		 5.5

    Secondary: Percentage of participants with a clinical response of cure at the Test of Cure Visit

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    End point title
    		 Percentage of participants with a clinical response of cure at the Test of Cure Visit
    End point description
    Clinical response of cure is complete resolution or marked improvement in signs and symptoms of the complicated urinary tract infection (cUTI) or return to pre-infection signs and symptoms, such that no further antibiotic therapy (IV or oral) is required for the treatment of the cUTI. The 95% CIs of each treatment are unstratified Wilson CIs. The population analyzed was all randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture.
    End point type
    Secondary
    End point timeframe
    Up to Test of Cure Visit (up to 35 days)
    End point values
    		 Ceftolozane/Tazobactam Meropenem
    Number of subjects analysed
    71
    24
    Units: Percentage of participants
        number (confidence interval 95%)
    88.7 (79.31 to 94.18)
    95.8 (79.76 to 99.26)
    Statistical analysis title
    		 Difference in Percentage (C/T minus Mero)
    Statistical analysis description
    The Miettinen & Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.
    Comparison groups
    Ceftolozane/Tazobactam v Meropenem
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -7.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.99
         upper limit
    		 10.05

    Secondary: Percentage of participants with a clinical response of cure at the End of Treatment Visit

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    End point title
    		 Percentage of participants with a clinical response of cure at the End of Treatment Visit
    End point description
    Clinical response of cure is complete resolution or marked improvement in signs and symptoms of the cUTI or return to pre-infection signs and symptoms, such that no further antibiotic therapy (IV or oral) is required for the treatment of the cUTI. The 95% CIs of each treatment are unstratified Wilson CIs. The population analyzed was all randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture.
    End point type
    Secondary
    End point timeframe
    Up to 48 hours after last oral dose (Up to 19 days)
    End point values
    		 Ceftolozane/Tazobactam Meropenem
    Number of subjects analysed
    71
    24
    Units: Percentage of participants
        number (confidence interval 95%)
    94.4 (86.39 to 97.79)
    100.0 (86.20 to 100.00)
    Statistical analysis title
    		 Difference in Percentage (C/T minus Mero)
    Statistical analysis description
    The Miettinen & Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.
    Comparison groups
    Ceftolozane/Tazobactam v Meropenem
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.09
         upper limit
    		 8.88

    Secondary: Percentage of participants with microbiological eradication of all baseline pathogens at the Test of Cure Visit

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    End point title
    		 Percentage of participants with microbiological eradication of all baseline pathogens at the Test of Cure Visit
    End point description
    Microbiological eradication of all baseline pathogens is defined as a postbaseline urine culture shows all uropathogens found at baseline at ≥10^5 colony-forming units (CFU)/mL are reduced to <10^4 CFU/mL. The 95% CIs of each treatment are unstratified Wilson CIs. The population analyzed was all randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture.
    End point type
    Secondary
    End point timeframe
    Up to Test of Cure Visit (up to 35 days)
    End point values
    		 Ceftolozane/Tazobactam Meropenem
    Number of subjects analysed
    71
    24
    Units: Percentage of participants
        number (confidence interval 95%)
    84.5 (74.35 to 91.12)
    87.5 (69.00 to 95.66)
    Statistical analysis title
    		 Difference in Percentage (C/T minus Mero)
    Statistical analysis description
    The Miettinen & Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.
    Comparison groups
    Ceftolozane/Tazobactam v Meropenem
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.13
         upper limit
    		 17.4

    Secondary: Percentage of participants with microbiological eradication of all baseline pathogens at the End of Treatment Visit

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    End point title
    		 Percentage of participants with microbiological eradication of all baseline pathogens at the End of Treatment Visit
    End point description
    Microbiological eradication of all baseline pathogens is defined as a postbaseline urine culture shows all uropathogens found at baseline at ≥10^5 CFU/mL are reduced to <10^4 CFU/mL. The 95% CIs of each treatment are unstratified Wilson CIs.The population analyzed was all randomized participants who received any amount of study treatment and have at least 1 acceptable causative uropathogen identified from a study-qualifying baseline urine culture.
    End point type
    Secondary
    End point timeframe
    Up to 48 hours after last oral dose (Up to 19 days)
    End point values
    		 Ceftolozane/Tazobactam Meropenem
    Number of subjects analysed
    71
    24
    Units: Percentage of participants
        number (confidence interval 95%)
    93.0 (84.55 to 96.95)
    95.8 (79.76 to 99.26)
    Statistical analysis title
    		 Difference in Percentage (C/T minus Mero)
    Statistical analysis description
    The Miettinen & Nurminen method stratified by age group with Cochran-Mantel-Haenszel (CMH) weights was used. If there was a zero count in any class of the stratum, the groups with the lower count were pooled with its near age group stratum in the model.
    Comparison groups
    Ceftolozane/Tazobactam v Meropenem
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage Difference
    Point estimate
    -3.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.67
         upper limit
    		 13.41

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs): From treatment (Day 1) up to 88 days. All-cause mortality: From randomization (Day 1) up to 88 days.
    Adverse event reporting additional description
    For all-cause mortality the population analyzed was all randomized participants. For AEs the population analyzed was all randomized participants who received any amount of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Meropenem
    Reporting group description
    		 Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for 7-14 days

    Reporting group title
    Ceftolozane/Tazobactam
    Reporting group description
    		 Ceftolozane 20 mg/kg and tazobactam 10 mg/kg (maximum 1 g and 0.5 g/dose) administered intravenously (IV) every 8 hours for 7-14 days

    Serious adverse events
    		 Meropenem Ceftolozane/Tazobactam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 33 (6.06%)
    3 / 100 (3.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Meropenem Ceftolozane/Tazobactam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 33 (30.30%)
    25 / 100 (25.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 33 (6.06%)
    4 / 100 (4.00%)
         occurrences all number
    2
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 33 (6.06%)
    4 / 100 (4.00%)
         occurrences all number
    2
    4
    Blood and lymphatic system disorders
    Thrombocytosis
         subjects affected / exposed
    3 / 33 (9.09%)
    7 / 100 (7.00%)
         occurrences all number
    3
    7
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 33 (0.00%)
    6 / 100 (6.00%)
         occurrences all number
    0
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 33 (9.09%)
    7 / 100 (7.00%)
         occurrences all number
    3
    7
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    2 / 33 (6.06%)
    2 / 100 (2.00%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    3 / 33 (9.09%)
    1 / 100 (1.00%)
         occurrences all number
    3
    1
    Vulvovaginitis
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 100 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2019
    Amendment 2 combined enrollment targets for groups 3-5 with a companion study of ceftolozane/tazobactam in pediatric complicated urinary tract infections. This allowed greater flexibility in enrollment targets for Groups 3-5 (the youngest cohort of children) and facilitated enrollment of a sufficient number of participants to evaluate safety and pharmacokinetics in both study populations and enabled timely completion of the studies.
    08 Oct 2020
    Amendment 3 removed the minimum number of at least 4 participants per study required to be enrolled in Groups 3, 4, and 5 and reduced minimum enrollment targets for Groups 3 and 5. Individual study age group minimum requirements for Groups 3-5 were removed to facilitate more timely availability of important pediatric data to health care providers and participants.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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