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    Clinical Trial Results:
    A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Meropenem in Hospitalized Children With Complicated Intra-Abdominal Infections.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2009-015864-32
    Trial protocol
    LT   LV   Outside EU/EEA  
    Global end of trial date
    09 Sep 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    09 Jun 2016
    First version publication date
    23 Jul 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    DORIPED3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01110382
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, 2340 Beerse , Belgium, Belgium,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group , Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000015-PIP01-07
    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
    09 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Sep 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of meropenem in hospitalized children 3 months to less than 18 years of age with cIAI (complicated intra-abdominal infection).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. An Independent Data Monitoring Committee [IDMC] monitored the safety of participants in this study as well as 2 additional Phase 3 paediatric trials being conducted by the Sponsor simultaneously. Safety evaluations included the measurement of vital signs, monitoring of reported adverse effects (AEs), including serious adverse effects (SAEs), concomitant therapy, serum chemistry, hematology assessments, and urinalysis with microscopy.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Nov 2010
    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
    Argentina: 4
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Colombia: 2
    Country: Number of subjects enrolled
    Lithuania: 10
    Country: Number of subjects enrolled
    Latvia: 6
    Country: Number of subjects enrolled
    Panama: 5
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    41
    EEA total number of subjects
    16
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    30
    Adolescents (12-17 years)
    11
    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
    Of the 41 participants, 31 participants were assigned to treatment with doripenem and 10 participants were assigned to treatment with meropenem.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Doripenem
    Arm description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium).

    Arm title
    Meropenem
    Arm description
    Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days.
    Arm type
    Active comparator

    Investigational medicinal product name
    Meropenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).

    Number of subjects in period 1
    Doripenem Meropenem
    Started
    31
    10
    Completed
    31
    8
    Not completed
    0
    2
         Other
    -
    1
         Consent withdrawn by subject
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days.

    Reporting group title
    Meropenem
    Reporting group description
    Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days.

    Reporting group values
    Doripenem Meropenem Total
    Number of subjects
    31 10 41
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    23 7 30
        Adolescents (12-17 years)
    8 3 11
        Adults (18-64 years)
    0 0 0
        From 65 to 84 years
    0 0 0
        85 years and over
    0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    8.5 ± 3.4 9.3 ± 4.52 -
    Title for Gender
    Units: subjects
        Female
    15 0 15
        Male
    16 10 26

    End points

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    End points reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days.

    Reporting group title
    Meropenem
    Reporting group description
    Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days.

    Subject analysis set title
    Clinical Intent-to-Treat (CITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomized participants who met the minimal disease definition of complicated intra-abdominal infection regardless if a baseline pathogen was isolated from the intra-abdominal cavity.

    Subject analysis set title
    Microbiological intent-to-treat
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants of CITT with at least 1 baseline bacterial pathogen isolated from the intra-abdominal cavity that was susceptible to both doripenem and meropenem. 8 and 2 participants from doripenem and meropenem, respectively had no susceptible intra-abdominal pathogen at baseline and were excluded from this set.

    Primary: The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit

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    End point title
    The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
    End point description
    The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favourable response at End of IV visit.
    End point type
    Primary
    End point timeframe
    TOC (7 to 14 days after the last dose of study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    31 [1]
    10 [2]
    Units: Participants
        number (not applicable)
    23
    7
    Notes
    [1] - Clinical Intent-to-Treat (CITT)
    [2] - Clinical Intent-to-Treat (CITT)
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Doripenem v Meropenem
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    Method
    Parameter type
    Difference clinical cure rates (%)
    Point estimate
    4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -34.7
         upper limit
    43.1
    Notes
    [3] - Descriptive study.

    Secondary: The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit

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    End point title
    The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit
    End point description
    The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in white blood cell (WBC) , and not received any non study antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun period at the end.
    End point type
    Secondary
    End point timeframe
    EIV (within 24 hours after completion of the last dose of IV study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    31 [4]
    10 [5]
    Units: Participants
        number (not applicable)
    29
    8
    Notes
    [4] - Clinical Intent-to-Treat (CITT)
    [5] - Clinical Intent-to-Treat (CITT)
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Doripenem v Meropenem
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    other [6]
    Method
    Parameter type
    Difference clinical improvement rates(%)
    Point estimate
    13.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.3
         upper limit
    46.4
    Notes
    [6] - Descriptive study.

    Secondary: The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit

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    End point title
    The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit
    End point description
    The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favourable response at End of IV visit.
    End point type
    Secondary
    End point timeframe
    LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    31 [7]
    10 [8]
    Units: Participants
        number (not applicable)
    22
    6
    Notes
    [7] - Clinical Intent-to-Treat (CITT)
    [8] - Clinical Intent-to-Treat (CITT)
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Doripenem v Meropenem
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    other [9]
    Method
    Parameter type
    Difference Clinical Cure Rate (%)
    Point estimate
    11
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -30
         upper limit
    51.9
    Notes
    [9] - Descriptive study.

    Secondary: The Number of Participants With Favorable Per-participant Microbiological Response

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    End point title
    The Number of Participants With Favorable Per-participant Microbiological Response
    End point description
    Favourable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favourable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
    End point type
    Secondary
    End point timeframe
    EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    23 [10]
    8 [11]
    Units: Participants
    number (not applicable)
        EIV visit
    21
    6
        TOC visit
    17
    5
        LFU visit
    17
    5
    Notes
    [10] - Microbiological intent-to-treat
    [11] - Microbiological intent-to-treat
    Statistical analysis title
    Favorable Microbiological Response (MR) at EIV.
    Comparison groups
    Doripenem v Meropenem
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    other [12]
    Method
    Parameter type
    Difference between MR rate (%)
    Point estimate
    16.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -24.3
         upper limit
    56.9
    Notes
    [12] - Descriptive study.
    Statistical analysis title
    Favorable Microbiological Response (MR) at TOC.
    Comparison groups
    Doripenem v Meropenem
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    other [13]
    Method
    Parameter type
    Difference between MR rate (%)
    Point estimate
    11.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.1
         upper limit
    57.9
    Notes
    [13] - Descriptive study.
    Statistical analysis title
    Favorable Microbiological Response (MR) at LFU
    Comparison groups
    Doripenem v Meropenem
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    other [14]
    Method
    Parameter type
    Difference between MR rate (%)
    Point estimate
    11.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -35.1
         upper limit
    57.9
    Notes
    [14] - Descriptive study.

    Secondary: Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit

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    End point title
    Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
    End point description
    A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
    End point type
    Secondary
    End point timeframe
    EIV (within 24 hours after completion of the last dose of IV study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    23 [15]
    8 [16]
    Units: Participants
    number (not applicable)
        Streptococcus anginosus (n=13, 0)
    12
    0
        Escherichia coli (n=19, 8)
    18
    6
        Bacteroides fragilis (n=11, 1)
    10
    1
    Notes
    [15] - Microbiological intent-to-treat
    [16] - Microbiological intent-to-treat
    No statistical analyses for this end point

    Secondary: Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit

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    End point title
    Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
    End point description
    A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
    End point type
    Secondary
    End point timeframe
    TOC (7 to 14 days after the last dose of study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    23 [17]
    8 [18]
    Units: Participants
    number (not applicable)
        Streptococcus anginosus (n=13, 0)
    9
    0
        Escherichia coli (n=19, 8)
    15
    5
        Bacteroides fragilis (n=11, 1)
    9
    1
    Notes
    [17] - Microbiological intent-to-treat
    [18] - Microbiological intent-to-treat
    No statistical analyses for this end point

    Secondary: Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit

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    End point title
    Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
    End point description
    A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
    End point type
    Secondary
    End point timeframe
    LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Meropenem
    Number of subjects analysed
    23 [19]
    8 [20]
    Units: Participants
    number (not applicable)
        Streptococcus anginosus (n=13, 0)
    9
    0
        Escherichia coli (n=19, 8)
    15
    5
        Bacteroides fragilis (n=11, 1)
    9
    1
    Notes
    [19] - Microbiological intent-to-treat
    [20] - Microbiological intent-to-treat
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose [mg/dose]) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 10 to 14 days.

    Reporting group title
    Meropenem
    Reporting group description
    Meropenem 20 milligram per kilogram [mg/kg] per dose (up to 1 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium).Total duration of treatment 10 to 14 days.

    Serious adverse events
    Doripenem Meropenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 31 (22.58%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional Gastrointestinal Disorder
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (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
    Abdominal Abscess
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Doripenem Meropenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 31 (67.74%)
    6 / 10 (60.00%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Procedural Site Reaction
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Seroma
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Blood Chloride Increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hepatic Enzyme Increased
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Ventricular Extrasystoles
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Catheter Site Inflammation
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infusion Site Pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Abdominal Pain
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Abdominal Tenderness
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Diarrhoea
         subjects affected / exposed
    1 / 31 (3.23%)
    2 / 10 (20.00%)
         occurrences all number
    1
    2
    Gastrointestinal Hypomotility
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Ileus
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Tongue Ulceration
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 31 (6.45%)
    2 / 10 (20.00%)
         occurrences all number
    2
    2
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Rash Papular
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Metabolism and nutrition disorders
    Hypervolaemia
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Abscess
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Otitis Media
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Peritonitis
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2011
    The overall reason for the amendment were: incorporate comments from regulatory authorities and investigators from around the world. There was change in meropenem time of intravenous bolus infusion from a 3 to 5 minute, to clarify directions and update the dosing of amoxicillin/clavulanate potassium to every 12 hours [q12h] (7:1 amoxicillin/clavulanate ratio), to allow subjects with negative intra-abdominal culture results to continue on study drug. Also to specify that subjects with recurrence of an intra-abdominal infection or who have failed prior surgical and/or medical therapy for a recent or ongoing infection may not enrol in the study. The amendment also includes the requirement that urinalysis with microscopy and creatinine clearance be calculated at baseline as well as to specify time points for the collection of safety laboratory tests. It also includes to align the protocol with the EU pediatric investigational plan (PIP) and to remove details of the IDMC that will be specified in the IDMC charter. The amended protocol includes to revise the pharmacokinetic sample collection and handling methods.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jun 2013
    This study was terminated early due to business reasons and not related to safety concerns or issues. NOTE: Interruption date indicates the date on which IDMC was notified of premature termination of trial.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The major limitation of the study was limited enrollment which precludes a meaningful conclusion about the efficacy and safety of doripenem compared with meropenem.
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