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    Clinical Trial Results:
    A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2009-016069-27
    Trial protocol
    LT   LV   Outside EU/EEA  
    Global end of trial date
    21 Mar 2012

    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
    DORIPED3003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01110421
    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
    21 Mar 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Mar 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2012
    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 of doripenem compared with that of cefepime in hospitalized children 3 months to less than 18 years of age with suspected bacterial pneumonia including NP (Nosocomial Pneumonia), VAP (Ventilator-Assiociated Pneumonia), and severe CAP (Community-Acquired Pneumonia).
    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 pediatric 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
    01 Dec 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
    Colombia: 2
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Ukraine: 1
    Worldwide total number of subjects
    7
    EEA total number of subjects
    4
    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)
    7
    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
    The study was planned to enroll a minimum of 120 participants but since it was terminated early (05 August 2013), only 7 participants were enrolled in this study at 1 center each in Poland, Ukraine, and Colombia.

    Pre-assignment
    Screening details
    A total of 7 participants (5 subjects in doripenem group and 2 subjects in cefepime group) were enrolled in this study.

    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, Carer, Assessor

    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 or ciprofloxacin). 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 or ciprofloxacin).

    Arm title
    Cefepime
    Arm description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV cefepime only or IV cefipime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days
    Arm type
    Active comparator

    Investigational medicinal product name
    Cefepime
    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
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV cefepime only or IV cefipime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin).

    Number of subjects in period 1
    Doripenem Cefepime
    Started
    5
    2
    Completed
    4
    2
    Not completed
    1
    0
         Adverse event, non-fatal
    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 or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group title
    Cefepime
    Reporting group description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV cefepime only or IV cefipime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days

    Reporting group values
    Doripenem Cefepime Total
    Number of subjects
    5 2 7
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    5 2 7
        Adolescents (12-17 years)
    0 0 0
        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)
    5.2 ( 2.49 ) 4.5 ( 0.71 ) -
    Title for Gender
    Units: subjects
        Female
    0 1 1
        Male
    5 1 6

    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 or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group title
    Cefepime
    Reporting group description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV cefepime only or IV cefipime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). 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 pneumonia regardless if a baseline pathogen was isolated from the baseline lower respiratory tract culture, pleural fluid or blood culture.

    Subject analysis set title
    Microbiological intent-to-treat(MITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants of CITT with at least one baseline pneumonia pathogen from pleural fluid, LRT, or blood culture susceptible to doripenem and cefepime. 3 and 2 participants from doripenem and cefepime, respectively had no susceptible pneumonia pathogens 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 [1]
    End point description
    The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia.
    End point type
    Primary
    End point timeframe
    TOC (7 to 14 days after the last dose of study medication therapy)
    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 Cefepime
    Number of subjects analysed
    5 [2]
    2 [3]
    Units: Participants
        number (not applicable)
    3
    2
    Notes
    [2] - Clinical intent-to-treat
    [3] - Clinical intent-to-treat
    No statistical analyses for this end point

    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
    Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia after IV study drug therapy had begun.
    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 Cefepime
    Number of subjects analysed
    5 [4]
    2 [5]
    Units: Participants
        number (not applicable)
    4
    2
    Notes
    [4] - Clinical intent-to-treat
    [5] - Clinical intent-to-treat
    No statistical analyses for this end point

    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 classified as clinical cure if all pretreatment signs and symptoms showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia.
    End point type
    Secondary
    End point timeframe
    LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    5 [6]
    2 [7]
    Units: Participants
        number (not applicable)
    3
    2
    Notes
    [6] - Clinical intent-to-treat
    [7] - Clinical intent-to-treat
    No statistical analyses for this end point

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

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    End point title
    The Number of Participants With Favorable Per-participant Microbiological Response Rate
    End point description
    Favorable 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 favorable 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.
    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 Cefepime
    Number of subjects analysed
    2 [8]
    0 [9]
    Units: Participants
    number (not applicable)
        TOC visit
    2
        EIV visit
    2
        LFU visit
    2
    Notes
    [8] - MITT
    [9] - 1) MITT 2) Participants had no susceptible pneumonia pathogens at baseline and were excluded
    No statistical analyses for this end point

    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 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.
    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 Cefepime
    Number of subjects analysed
    2 [10]
    0 [11]
    Units: Participants
    number (not applicable)
        Staphylococcus aureus (n=1)
    1
        Streptococcus pneumoniae (n=1)
    1
        Klebsiella pneumoniae (n=1)
    1
    Notes
    [10] - MITT
    [11] - 1) MITT 2) Participants had no susceptible pneumonia pathogens at baseline and were excluded.
    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 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.
    End point type
    Secondary
    End point timeframe
    TOC (7 to 14 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    2 [12]
    0 [13]
    Units: Participants
    number (not applicable)
        Staphylococcus aureus (n=1)
    1
        Streptococcus pneumoniae (n=1)
    1
        Klebsiella pneumoniae (n=1)
    1
    Notes
    [12] - MITT
    [13] - 1) MITT 2) Participants had no susceptible pneumonia pathogens at baseline and were excluded.
    No statistical analyses for this end point

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

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    End point title
    Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
    End point description
    A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable 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). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis.
    End point type
    Secondary
    End point timeframe
    LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    2 [14]
    0 [15]
    Units: Participants
    number (not applicable)
        Staphylococcus aureus (n=1)
    1
        Streptococcus pneumoniae (n=1)
    1
        Klebsiella pneumoniae (n=1)
    1
    Notes
    [14] - MITT
    [15] - 1) MITT 2) Participants had no susceptible pneumonia pathogens at baseline and were excluded.
    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
    15.1
    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 or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group title
    Cefepime
    Reporting group description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (at least 3 days of IV cefepime only or IV cefipime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days

    Serious adverse events
    Doripenem Cefepime
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Empyema
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (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: 5%
    Non-serious adverse events
    Doripenem Cefepime
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 2 (50.00%)
    Investigations
    Oxygen Saturation Decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Stab Wound
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nasal Congestion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Flank Pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Apr 2011
    The overall reason for the amendment is to incorporate comments from regulatory authorities and investigators from around the world and update the dosing of amoxicillin/clavulanate potassium to every 12 hours every 12 hours [q12h] (7:1 amoxicillin/clavulanate ratio). It includes the clarifications for the doripenem phase 3 program also to clarify that subjects should not receive non study systemic antibacterial therapy for more than 24 hours before the first dose of study drug and to remove CPIS from the study since it has not been validated as a criterion of improvement for children on mechanical ventilation.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 test. The amendment incorporate to allow subjects to continue adjunctive therapy when switched to oral medication and to update the dosing of amoxicillin/clavulanate potassium. 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
    13 Feb 2012
    On 13 February 2012, the FDA placed the DORIPED3003 Study on clinical hold until after they were able to fully review the “DORINOS3008” final clinical study report and assure the patient population to be enrolled in this trial was not placed under undue risk. At the time the trial was terminated, the clinical hold had not been lifted. In addition, the Paediatric Committee (PDCO) requested that, before the trial DORIPED-3003 can be restarted, the doripenem dosing to be used in this trial be agreed by the PDCO based on providing the full assessment of the adult study DORI-NOS-3008. Trial was terminated prior to this occurring.
    -

    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 cefepime.
    For support, Contact us.
    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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