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    Clinical Trial Results:
    An open-label study to evaluate the penetration of doripenem in cerebrospinal fluid after doripenem administration in pediatric subjects less than 1 year chronological age

    Summary
    EudraCT number
    		 2011-001114-33
    Trial protocol
    		 BE   PL  
    Global end of trial date
    02 Jun 2012

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

    Trial information

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    Trial identification
    Sponsor protocol code
    DORIPED1002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01366651
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV,Janssen Research & Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV,Janssen Research & Development, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jun 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jun 2012
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric participants less then (<1) year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.
    Protection of trial subjects
    Safety evaluation included following assessments: Physical examinations including body weigh ,Vital sign measurements included blood pressure, pulse rate, respiratory rate (and documentation if a participants was on a ventilator or not), and temperature (skin probe, rectal, axillary, or other) was examined.Vital signs were measured before the start of study drug infusion and within 15 minutes after the end of each doripenem infusion. Adverse events were reported throughout the study.This study was conducted in compliance with the protocol, Good Clinical Practice, and applicable regulatory requirements. A safety committee composed of the medical monitor, 1 of the study’s investigators, and 1 expert in paediatrics reviewed the safety while the study was on-going.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    1
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    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
    		 One participant was enrolled into the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Doripenem
    Arm description
    		 Doripenem was administered as intravenous infusion for 1 hour every 8 hours at a concentration of 10 milligram per milliliter (mg/ml). The doripenem dose was 10 milligram per kilogram (mg/kg) for participants less than 12 weeks and 30 mg/kg for participants 12 weeks to less than one year of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    JNJ-38174942
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Doripenem was administered as intravenous infusion for 1 hour every 8 hours at a concentration of 10 milligram per milliliter (mg/ml). Total dose was 10 milligram per kilogram (mg/kg) for participants of less than 12 weeks and 30 mg/kg for participants of 12 weeks to less than one year.

    Number of subjects in period 1
    		Doripenem
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    		 Doripenem was administered as intravenous infusion for 1 hour every 8 hours at a concentration of 10 milligram per milliliter (mg/ml). The doripenem dose was 10 milligram per kilogram (mg/kg) for participants less than 12 weeks and 30 mg/kg for participants 12 weeks to less than one year of age.

    Reporting group values
    		 Doripenem Total
    Number of subjects
    		 1 1
    Title for AgeCategorical
    Units: subjects
        Newborns (0-27 days)
    		 1 1
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65 to 84 years
    		 0 0
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: days
        arithmetic mean (standard deviation)
    		 3.7 ± 0 -
    Title for Gender
    Units: subjects
        Female
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    		 Doripenem was administered as intravenous infusion for 1 hour every 8 hours at a concentration of 10 milligram per milliliter (mg/ml). The doripenem dose was 10 milligram per kilogram (mg/kg) for participants less than 12 weeks and 30 mg/kg for participants 12 weeks to less than one year of age.

    Primary: Doripenem concentration in Cerebrospinal fluid

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    End point title
    		 Doripenem concentration in Cerebrospinal fluid [1]
    End point description
    Doripenem concentration was analyzed by validated, specific and sensitive liquid-chromatography/tandem mass spectrometry (LC-MS/MS) method.
    End point type
    Primary
    End point timeframe
    17 minutes after end of Doripenem one hour infusion
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Doripenem
    Number of subjects analysed
    1
    Units: Microgram per milliliter (µg/mL)
        number (not applicable)
    0.331
    No statistical analyses for this end point

    Primary: Doripenem concentration in Plasma

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    End point title
    		 Doripenem concentration in Plasma [2]
    End point description
    Doripenem concentration was analyzed by validated, specific and sensitive liquid-chromatography/tandem mass spectrometry (LC-MS/MS) method.
    End point type
    Primary
    End point timeframe
    10,29 minutes after end of Doripenem one hour infusion
    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: Descriptive statistics were done, no inferential statistical analyses were performed
    End point values
    		 Doripenem
    Number of subjects analysed
    1
    Units: Microgram per milliliter (µg/mL)
    number (not applicable)
        10
    26.6
        29
    24.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 9.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    		 Doripenem was administered as intravenous infusion for 1 hour every 8 hours at a concentration of 10 milligram per milliliter (mg/ml). Total dose was 10 milligram per kilogram (mg/kg) for participants of less than 12 weeks and 30 mg/kg for participants of 12 weeks to less than one year.

    Serious adverse events
    		 Doripenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Doripenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious AEs reported.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2011
    This amendment is considered to be substantial. The overall reason for the amendment is to provide clarification on a number of items and to align the protocol with recommended from investigators. It includes that the Body weight was not be collected on the day of the first doripenem infusion (Day 1). To specify the age of participants to be enrolled in days. To clarify the vital signs to be collected in the footnote of the Time & Events Schedule. To clarify the amount of time allowed between the start of the doripenem administration and the End-of-Study assessment and that CSF samples must be obtained from only a LP or VP shunt tap and that CSF sampling by other methods is not allowed. To clarify that the exclusion criteria to provide examples of the types of blood components not permitted to be administered and when. To avoid disruption of the equilibrium between plasma doripenem concentrations and CSF doripenem concentrations on study days when both samples was collected. To clarify the acceptable timeframe for eCRFs must be completed. The Centrifugation of the CSF samples is requested to avoid potential contamination of CSF with doripenem from blood components. To reduce possible physiologic variability that may confound the interpretation of pharmacokinetic data and clarification that participants should not have received an investigational compound (rather than having participated in a clinical study) within 2 weeks of the first dose of doripenem in this study. To clarify that participants with hematocrit level <30% are excluded from study participation. The timing of drawing of blood samples to match the CSF sample was clarified to avoid misunderstanding of the instructions.

    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.
    The objectives of study could not be achieved as study was terminated early on 1-july-2013 for business reasons, and is not related to any safety issues or concerns. Only 1 participant was enrolled into the study.
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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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