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    Clinical Trial Results:
    Multinational, Randomized, Double Blind, Comparative Study to Evaluate The Efficacy and Safety of Telithromycin, 800 mg Once Daily for 5 Days, Versus Penicillin V, 500 mg Three Times Daily for 10 Days, In Adolescent and Adult Subjects Equal to or Over 13 Years of Age With Streptococcus Pyogenes Tonsillitis/Pharyngitis

    Summary
    EudraCT number
    		 2014-004631-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Sep 2007

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

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC6134, HMR3647B/3006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00315549
    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
    03 Jun 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) in the per-protocol population for analysis of bacteriologic outcome (PPb).
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates. 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
    20 Feb 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: 233
    Worldwide total number of subjects
    233
    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)
    0
    Adolescents (12-17 years)
    79
    Adults (18-64 years)
    153
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 41 sites in United States of America.  A total of 256 subjects were screened between 20 February 2006 and 7 June 2006.

    Pre-assignment
    Screening details
    		 Of 256 screened subjects, 233 subjects were randomized.

    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 and placebo for 10 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Telithromycin
    Investigational medicinal product code
    HMR3647
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Telithromycin tablet over-encapsulated 800 mg once daily.

    Investigational medicinal product name
    Placebo (for Penicillin V)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to Penicillin V 3 times daily for 10 days.

    Arm title
    		 Penicillin V
    Arm description
    		 Penicillin V for 10 days and placebo for 5 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Penicllin V potassium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Penicllin V tablet over-encapsulated 500 mg three times daily.

    Investigational medicinal product name
    Placebo (for Telithromycin)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    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
    112
    121
    Treated
    112
    120
    Completed
    97
    103
    Not completed
    15
    18
         Consent withdrawn by subject
    2
    -
         Randomized but not treated
    -
    1
         Adverse event
    7
    5
         Unspecified
    -
    2
         Lost to follow-up
    5
    6
         Lack of efficacy
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days and placebo for 10 days.

    Reporting group title
    Penicillin V
    Reporting group description
    		 Penicillin V for 10 days and placebo for 5 days.

    Reporting group values
    		 Telithromycin Penicillin V Total
    Number of subjects
    		 112 121 233
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 37 42 79
        Adults (18-64 years)
    		 75 78 153
        From 65-84 years
    		 0 1 1
    Gender categorical
    Units: Subjects
        Female
    		 77 76 153
        Male
    		 35 44 79
        Not available
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days and placebo for 10 days.

    Reporting group title
    Penicillin V
    Reporting group description
    		 Penicillin V for 10 days and placebo for 5 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 post therapy (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 233 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
    71
    84
    Units: percentage of subjects
    number (not applicable)
        Bacteriologic Cure (Documented Eradication)
    93
    83.3
        Bacteriologic Failure (Documented Persistence)
    7
    16.7
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects According to Bacteriological Outcome in Bacteriological Modified Intent to Treat (mITTb) Population
    End point description
    Analysis was carried out on bmITT population defined as the bacteriological modified intent to treat population that included all subjects that were in the mITT population with isolation of S. pyogenes at Visit 1.
    End point type
    Secondary
    End point timeframe
    At post therapy (Day 13-17)
    End point values
    		 Telithromycin Penicillin V
    Number of subjects analysed
    84
    96
    Units: percentage of subjects
    number (not applicable)
        Bacteriologic Cure (Documented Eradication)
    85.7
    77.1
        Bacteriologic Failure (Documented Persistence)
    7.1
    14.6
        Bacteriologic Indeterminate
    7.1
    8.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects According to Bacteriological Outcome in PPb Population (At Late Post Therapy)

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    End point title
    		 Percentage of Subjects According to Bacteriological Outcome in PPb Population (At Late Post Therapy)
    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 post therapy (Day 38-45)
    End point values
    		 Telithromycin Penicillin V
    Number of subjects analysed
    56
    67
    Units: percentage of subjects
    number (not applicable)
        Bacteriologic Cure (Documented Eradication)
    94.6
    91
        Bacteriologic Failure (Documented Persistence)
    5.4
    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
    112
    120
    Units: subjects
        Cardiac events
    0
    0
        Hepatic events
    5
    2
        Visual disturbances
    3
    3
    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 (Days 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
    Penicillin
    Reporting group description
    		 Penicillin V for 10 days and placebo for 5 days.

    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days and placebo for 10 days.

    Serious adverse events
    		 Penicillin Telithromycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 120 (0.83%)
    1 / 112 (0.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Liver Function Test Abnormal
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual Tracking Test Abnormal
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Serum Sickness
         subjects affected / exposed
    0 / 120 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute Sinusitis
         subjects affected / exposed
    1 / 120 (0.83%)
    0 / 112 (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
    		 Penicillin Telithromycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 120 (1.67%)
    11 / 112 (9.82%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 120 (1.67%)
    11 / 112 (9.82%)
         occurrences all number
    2
    14

    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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