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    Clinical Trial Results:
    Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days of Telithromycin Oral Suspension 25 mg/kg, Given Once Daily, Versus 5 Days of Azithromycin Oral Suspension, Given Once as 10 Mg/Kg Followed by 5 Mg/Kg Given Once Daily for 4 Days, in Children With Acute Otitis Media

    Summary
    EudraCT number
    		 2014-004637-47
    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
    03 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC6132, HMR3647B/3002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00315003
    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
    22 Sep 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
    The primary objective of this study was to assess the efficacy of telithromycin versus azithromycin in children with acute otitis media (AOM) with regard to superiority of time to symptom resolution in the modified intent-to-treat (mITT) population and noninferiority of clinical outcome at the test-of-cure (TOC) visit (Days 13 to 17) in the per protocol (PPc) population.
    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
    30 Jan 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: 321
    Worldwide total number of subjects
    321
    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)
    49
    Infants and toddlers (28 days-23 months)
    103
    Children (2-11 years)
    169
    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 27 sites in the United States. A total of 346 subjects were screened between 30 January 2006 and 8 June 2006.

    Pre-assignment
    Screening details
    		 Of 346 screened subjects, 321 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.
    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 (not to exceed 1200 mg/day).

    Investigational medicinal product name
    Placebo for Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to azithromycin for 5 days.

    Arm title
    		 Azithromycin
    Arm description
    		 Azithromycin for 5 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azithromycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg/kg once on Day 1 followed by 5 mg/kg on Days 2-5 (not to exceed 500 mg on Day 1 and 250 mg/day on Days 2-5).

    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 for 5 days.

    Number of subjects in period 1 [1]
    		Telithromycin Azithromycin
    Started
    156
    163
    Treated
    157
    161
    Completed
    141
    155
    Not completed
    17
    8
         Randomized but not treated
    1
    2
         Adverse event
    2
    2
         Subject did not wish to continue
    3
    -
         Unspecified
    6
    -
         Lost to follow-up
    1
    2
         Lack of efficacy
    4
    2
    Joined
    2
    0
         Transferred in from other group/arm
    2
    -
    Notes
    [1] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
    Justification: Two subjects were initially randomized to Azithromycin group but actually received Telithromycin. Hence these two subjects were considered in Telithromycin group (Transferred in from other group/arm).

    Baseline characteristics

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

    Reporting group title
    Azithromycin
    Reporting group description
    		 Azithromycin for 5 days.

    Reporting group values
    		 Telithromycin Azithromycin Total
    Number of subjects
    		 158 163 321
    Age categorical
    Units: Subjects
        Newborns (0-27 days)
    		 28 21 49
        Infants and toddlers (28 days-23 months)
    		 45 58 103
        Children (2-11 years)
    		 85 84 169
    Gender categorical
    Units: Subjects
        Female
    		 70 70 140
        Male
    		 87 93 180
        Not available
    		 1 0 1

    End points

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

    Reporting group title
    Azithromycin
    Reporting group description
    		 Azithromycin for 5 days.

    Primary:  Percentage of Subjects According to Clinical Outcome in Clinically Evaluable Per ­Protocol (PPc) Population

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    End point title
    		  Percentage of Subjects According to Clinical Outcome in Clinically Evaluable Per ­Protocol (PPc) Population [1]
    End point description
    Clinical cure was defined as absence of acute otitis media AOM-related fever, improvement in tympanic membrane and no need for surgical procedure/antibacterial administration for AOM or its complications. A subject was considered a clinical failure if a surgical procedure was performed. PPc population is defined as subjects randomized and treated and excluding for major protocol deviations, or classified as clinically indeterminate.
    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 321 subjects / 1500 planned) the type II error was not controlled as planned and only descriptive statistics were generated.
    End point values
    		 Telithromycin Azithromycin
    Number of subjects analysed
    130
    139
    Units: percentage of subjects
    number (not applicable)
        Cure
    78.5
    82.7
        Failure
    21.5
    17.3
    No statistical analyses for this end point

    Primary: Time to Symptom Resolution in Modified Intent To Treat (mITT) Population

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    End point title
    		 Time to Symptom Resolution in Modified Intent To Treat (mITT) Population [2]
    End point description
    The definition of resolution of symptoms was based on fever and the 4 components: ear pain, appetite, behavior, and nighttime sleep. mITT population was defined as all randomized and treated subjects. Protocol deviations were not considered and indeterminate clinical outcome were considered as failure. One subject in the azithromycin group was excluded in mITT population due to lack of confirmation of AOM.
    End point type
    Primary
    End point timeframe
    At posttherapy (Day 13-17)
    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: This study was terminated early (randomization of 321 subjects / 1500 planned) the type II error was not controlled as planned and only descriptive statistics were generated.
    End point values
    		 Telithromycin Azithromycin
    Number of subjects analysed
    155
    162
    Units: days
        median (inter-quartile range (Q1-Q3))
    3 (1.5 to 5)
    2.75 (1.5 to 5)
    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 defined as all randomized and treated subjects .Two subjects were randomized to receive azithromycin, but received telithromycin and were included included in the telithromycin safety population.
    End point type
    Secondary
    End point timeframe
    Study duration up to 28 Days
    End point values
    		 Telithromycin Azithromycin
    Number of subjects analysed
    157
    161
    Units: subjects
        Cardiac events
    0
    0
        Hepatic events
    0
    0
        Visual disturbances
    1
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects According to Clinical Outcome in mITT Population

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    End point title
    		 Percentage of Subjects According to Clinical Outcome in mITT Population
    End point description
    Clinical outcome is defined in first primary end point section. Analysis was carried out on mITT population.
    End point type
    Secondary
    End point timeframe
    At posttherapy (Day 13-17)
    End point values
    		 Telithromycin Azithromycin
    Number of subjects analysed
    155
    162
    Units: percentage of subjects
    number (not applicable)
        Cure
    69
    74.7
        Failure
    31
    25.3
    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 (Day 24-28) 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
    Azithromycin
    Reporting group description
    		 Azithromycin for 5 days.

    Reporting group title
    Telithromycin
    Reporting group description
    		 Telithromycin for 5 days.

    Serious adverse events
    		 Azithromycin Telithromycin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 157 (0.64%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Viral Infection
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 157 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Azithromycin Telithromycin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 161 (8.70%)
    18 / 157 (11.46%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 161 (4.97%)
    10 / 157 (6.37%)
         occurrences all number
    9
    10
    Infections and infestations
    Otitis Media
         subjects affected / exposed
    8 / 161 (4.97%)
    9 / 157 (5.73%)
         occurrences all number
    9
    9

    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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