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    Clinical Trial Results:
    Multinational, randomized, double blind, double dummy, pharmacokinetic study of telithromycin oral suspension (25 mg/kg once daily for 7-10 days), with secondary assessments of safety relative to azithromycin oral suspension (10 mg/kg once daily for 1 day followed by 5 mg/kg once daily for 4 days) in children with mild to moderate community-acquired pneumonia

    Summary
    EudraCT number
    		 2014-002867-13
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Sep 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    14 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    POP6135,HMR3647B/3005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi U.S Services Inc.
    Sponsor organisation address
    55 Corporate Drive Bridgewater,, New Jersey,, United States, 08807
    Public contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.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
    13 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2007
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the steady state pharmacokinetics of telithromycin oral suspension (25 mg/kg once a day for 7-10 days), in children 6 months to less than 13 years of age (<13) with community acquired pneumonia (CAP).
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in childappropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 May 2006
    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
    United States: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    0
    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)
    1
    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 conducted at one site in the United States. Enrolment was terminated after only one subject was recruited.

    Pre-assignment
    Screening details
    		 The subject was randomized in theTelithromycin arm. And so no subject was randomized in the Azithromycin arm (active comparator).

    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, Assessor

    Arms
    Arm title
    		 Telithromycin
    Arm description
    		 Telithromycin for 7-10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Telithromycin
    Investigational medicinal product code
    HMR3647B
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg/kg once daily.

    Investigational medicinal product name
    Placebo (for Azithromycin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo (for azithromycin) once daily.

    Number of subjects in period 1
    		Telithromycin
    Started
    1
    Treated
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 7-10 days.

    Reporting group values
    		 Telithromycin Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 1 1
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 7-10 days.

    Primary: Telithromycin plasma concentration

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    End point title
    		 Telithromycin plasma concentration [1]
    End point description
    End point type
    Primary
    End point timeframe
    (Day 6-10) end of treatment
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No analyze was performed because of the early termination after one subject was enrolled.
    End point values
    		 Telithromycin
    Number of subjects analysed
    0 [2]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    Notes
    [2] - Analyze not performed because of the early termination after one subject was enrolled.
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events of special interest

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    End point title
    		 Number of subjects with adverse events of special interest
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Day 17-24 post-therapy
    End point values
    		 Telithromycin
    Number of subjects analysed
    1
    Units: Subjects
        Cardiac events
    0
        Hepatic events
    0
        Visual disturbances
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (day 17 to 24) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 -

    Serious adverse events
    		 Telithromycin
    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
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Telithromycin
    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: No adverse event reported in this project

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2006
    This amendment has two objectives: 1. Include exclusion criteria for subjects at risk for respiratory distress. 2. To include the collection of sputum for Gram stain and culture and information about handling of microbiology specimens. The adjustments are supported by a request from the FDA.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jun 2006
    In June 2006, the Sponsor voluntarily paused enrollment in pediatric clinical trials with no subsequent recruitment of subjects. On 13 September 2007, the Sponsor informed the study sites that the trial was terminated.
    -

    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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