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    Clinical Trial Results:
    Multinational, Randomized, Double Blind, Double Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Oral Suspension, 25 mg/kg Once Daily for 5 Days, Versus Penicillin V Oral Solution, 13.3 mg/kg Three Times Daily for 10 Days, in Children 6 Months to Less Than 13 Years of Age with Streptococcus Pyogenes Tonsillitis/Pharyngitis

    Summary
    EudraCT number
    		 2014-004630-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Sep 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2016
    First version publication date
    28 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC6133, HMR3647B/3004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00315042
    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 & développement , Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement , 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
    27 May 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Sep 2007
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary objective of this study was to compare the bacteriologic efficacy of 5 days of telithromycin to 10 days of penicillin V in subjects with baseline bacterial throat culture positive for Streptococcus pyogenes (S. pyogenes) and repeat throat culture performed at the posttherapy/test-of-cure visit (Visit 3, Days 13 to 17) (per-protocol population for bacteriologic outcome [PPb]).
    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 child-appropriate 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
    12 Mar 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: 314
    Worldwide total number of subjects
    314
    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)
    2
    Infants and toddlers (28 days-23 months)
    7
    Children (2-11 years)
    289
    Adolescents (12-17 years)
    16
    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 43 sites in the United States of America. A total of 314 subjects were randomized between 12 March 2006 and 8 June 2006.

    Pre-assignment
    Screening details
    		 Of 314 randomized subjects, 305 subjects were treated.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Telithromycin
    Arm description
    		 Telithromycin for 5 days.
    Arm type
    		 Experimental

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

    Investigational medicinal product name
    Placebo (for Penicillin V)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to penicillin V, 3 times daily for 10 day.

    Arm title
    		 Penicillin V
    Arm description
    		 Penicillin V for 10 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Penicillin V Potassium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    13.3 mg/kg 3 times daily.

    Investigational medicinal product name
    Placebo (for Telithromycin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to telithromycin once daily for 5 days.

    Number of subjects in period 1
    		Telithromycin Penicillin V
    Started
    155
    159
    Treated
    150
    155
    Completed
    126
    139
    Not completed
    29
    20
         Consent withdrawn by subject
    8
    5
         Randomized but not treated
    5
    4
         Adverse event
    7
    4
         Unspecified
    3
    5
         Lost to follow-up
    5
    1
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days.

    Reporting group title
    Penicillin V
    Reporting group description
    		 Penicillin V for 10 days.

    Reporting group values
    		 Telithromycin Penicillin V Total
    Number of subjects
    		 155 159 314
    Age categorical
    Units: Subjects
        Newborns (0-27 days)
    		 0 2 2
        Infants and toddlers (28 days-23 months)
    		 4 3 7
        Children (2-11 years)
    		 141 148 289
        Adolescents (12-17 years)
    		 10 6 16
    Gender categorical
    Units: Subjects
        Female
    		 70 79 149
        Male
    		 85 80 165

    End points

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    End points reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days.

    Reporting group title
    Penicillin V
    Reporting group description
    		 Penicillin V for 10 days.

    Primary: Percentage of Subjects According to Bacteriological Outcome in  Bacteriological Per Protocol (PPb) Population

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    End point title
    		 Percentage of Subjects According to Bacteriological Outcome in  Bacteriological Per Protocol (PPb) Population [1]
    End point description
    Bacteriologic cure was defined as eradication of S. pyogenes at postbaseline culture (documented eradication). Bacteriologic failure was defined to occur if after 72 hours of study medication, a subject had a positive repeat postbaseline throat culture for S. pyogenes. The PPb population was defined as the per protocol population for analysis of bacteriologic outcome. The PPb population contained all subjects of the clinical per-protocol population (PPc) population with isolation of S. pyogenes at Visit 1 and a postbaseline culture at the Visit 3 and/or Visit 4 time window excluding the major protocol violations. Bacteriologic outcome assessment was made for the visit window in which the culture was obtained.
    End point type
    Primary
    End point timeframe
    At posttherapy (Day 13-17)
    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: This study was terminated early (randomization of 314 subjects/760 planned) the type II error was not controlled as planned and only descriptive statistics were generated.
    End point values
    		 Telithromycin Penicillin V
    Number of subjects analysed
    95
    104
    Units: percentage of subjects
    number (not applicable)
        Bacteriologic Cure (Documented Eradication)
    93.7
    74
        Bacteriologic Failure (Documented Persistence)
    6.3
    26
    No statistical analyses for this end point

    Secondary: Percentage of Subjects According to Bacteriological Outcome in Bacteriologic Modified Intent-to-Treat (bmITT) Population

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    End point title
    		 Percentage of Subjects According to Bacteriological Outcome in Bacteriologic Modified Intent-to-Treat (bmITT) Population
    End point description
    Analysis was carried out on bmITT population defined as the bacteriologic modified intent to treat population that included all subjects that were in the modified intent-to-treat (mITT) population with isolation of S. pyogenes at Visit 1.
    End point type
    Secondary
    End point timeframe
    At posttherapy (Day 13-17)
    End point values
    		 Telithromycin Penicillin V
    Number of subjects analysed
    124
    135
    Units: percentage of subjects
    number (not applicable)
        Bacteriologic Cure (Documented Eradication)
    80.6
    64.4
        Bacteriologic Failure (Documented Persistence)
    5.6
    21.5
        Bacteriologic Indeterminate
    13.7
    14.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects According to Bacteriological Outcome in PPb Population in Late Posttherapy

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    End point title
    		 Percentage of Subjects According to Bacteriological Outcome in PPb Population in Late Posttherapy
    End point description
    Bacteriologic cure was defined as eradication of S. pyogenes at postbaseline culture (documented eradication).Bacteriologic failure was defined to occur if after 72 hours of study medication, a subject had a positive repeat postbaseline throat culture for S. pyogenes. Analysis was performed on PPb population. Number of subjects analysed = subjects with data available at Day 38-45.
    End point type
    Secondary
    End point timeframe
    At late posttherapy (Day 38-45)
    End point values
    		 Telithromycin Penicillin V
    Number of subjects analysed
    80
    92
    Units: percentage of subjects
    number (not applicable)
        Bacteriologic Cure (Documented Eradication)
    88.8
    76.1
        Bacteriologic Failure (Documented Persistence)
    11.3
    23.9
    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
    Analysis was carried out on safety population which included all randomized and treated subjects.
    End point type
    Secondary
    End point timeframe
    7 days after end of treatment
    End point values
    		 Telithromycin Penicillin V
    Number of subjects analysed
    150
    155
    Units: subjects
        Cardiac events
    0
    0
        Hepatic events
    1
    0
        Visual disturbances
    1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 38-45) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (first dose of study medication and up to 7 days after the last dose of study medication or, up to 17 days after the first dose of study medication, whichever is later).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days.

    Reporting group title
    Penicillin V
    Reporting group description
    		 Penicillin V for 10 days.

    Serious adverse events
    		 Telithromycin Penicillin V
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 155 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 150 (0.67%)
    0 / 155 (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
    		 Telithromycin Penicillin V
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 150 (7.33%)
    5 / 155 (3.23%)
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    11 / 150 (7.33%)
    5 / 155 (3.23%)
         occurrences all number
    11
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    27 Jun 2006
    In June 2006, the Sponsor voluntarily paused enrollment in pediatric clinical trials with no subsequent recruitment of subjects. On 20 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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