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    Clinical Trial Results:
    An Open-Label, Non-Comparative Study to Assess the Pharmacokinetics, Safety and Efficacy of Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days in the Treatment of Uncomplicated Skin and Skin Structure Infections in Pediatric Subjects Aged 2 to 24 Months

    Summary
    EudraCT number
    		 2006-003374-10
    Trial protocol
    		 DE   NL  
    Global end of trial date
    18 Aug 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 May 2016
    First version publication date
    31 Jan 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TOC106489
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 8664357343,
    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
    26 Sep 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the systemic exposure, by using pharmacokinetic (PK) sampling at four to eight hours post-dose, of Retapamulin Ointment, 1%, when applied topically, twice daily for five days, in the treatment of pediatric subjects aged ≥2 to ≤6 months, >6 to ≤12 months, and >12 to ≤24 months with uncomplicated skin and skin structure infections, including secondarily-infected traumatic lesions (SITL), secondarily-infected dermatoses (SID) and impetigo.
    Protection of trial subjects
    Written, dated informed consent required from parent or guardian for all participants, where study procedures and any associated pain or discomfort were described.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Chile: 10
    Country: Number of subjects enrolled
    Costa Rica: 11
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    South Africa: 45
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    86
    EEA total number of subjects
    6
    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)
    86
    Children (2-11 years)
    0
    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
    		 Participants were recruited from 10 sites in 7 countries.

    Pre-assignment
    Screening details
    		 Participants eligible for enrollment in the study must have met all inclusion criteria.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Retapamulin Ointment, 1%
    Arm description
    		 Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Retapamulin 1% ointment
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Using a sterile swab, retapamulin ointment was applied, in an approximately 1 millimeter (mm)-thick layer, over the entire cleansed lesion(s). Ointment was applied twice daily at 10-hour to 12-hour intervals for 5 days. The area to be treated was not to exceed 2% body surface area (BSA).

    Number of subjects in period 1
    		Retapamulin Ointment, 1%
    Started
    86
    Completed
    78
    Not completed
    8
         Consent withdrawn by subject
    2
         Adverse event, non-fatal
    3
         Lost to follow-up
    2
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Retapamulin Ointment, 1%
    Reporting group description
    		 Retapamulin ointment, 1%, administered twice daily for 5 consecutive days

    Reporting group values
    		 Retapamulin Ointment, 1% Total
    Number of subjects
    		 86 86
    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)
    		 86 86
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.6 ± 6.89 -
    Gender categorical
    Units: Subjects
        Female
    		 32 32
        Male
    		 54 54
    Race, customized
    Units: Subjects
        African American/African Heritage
    		 46 46
        White/Caucasian
    		 36 36
        American Indian or Alaska Native
    		 1 1
        Central/South Asian
    		 1 1
        East Asian
    		 1 1
        Missing
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Retapamulin Ointment, 1%
    Reporting group description
    		 Retapamulin ointment, 1%, administered twice daily for 5 consecutive days

    Primary: Number of participants with measurable plasma concentrations, by age group

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    End point title
    		 Number of participants with measurable plasma concentrations, by age group [1]
    End point description
    Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4 . The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL. PK Population: all participants who received at least one dose of study medication and who had PK samples taken.
    End point type
    Primary
    End point timeframe
    Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day
    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 statistical analysis was conducted; thus, there are no statistical data to report.
    End point values
    		 Retapamulin Ointment, 1%
    Number of subjects analysed
    79 [2]
    Units: participants
        All ages
    36
        ≥2 months to ≤6 months
    17
        >6 months to ≤12 months
    10
        >12 months to ≤24 months
    9
    Notes
    [2] - Pharmacokinetic (PK) Population. Seven participants did not have PK samples collected.
    No statistical analyses for this end point

    Secondary: Number of participants with Clinical Success at Follow-up, by Type of Skin Infection and by Age

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    End point title
    		 Number of participants with Clinical Success at Follow-up, by Type of Skin Infection and by Age
    End point description
    SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed. Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication.
    End point type
    Secondary
    End point timeframe
    Follow-up, Days 12 to 16
    End point values
    		 Retapamulin Ointment, 1%
    Number of subjects analysed
    86 [3]
    Units: participants
        Impetigo, ≥2 months to ≤6 months, n=11
    10
        Impetigo, >6 months to ≤12 months, n=18
    17
        Impetigo, >12 months to ≤24 months, n=18
    17
        SID, ≥2 months to ≤6 months, n=17
    11
        SID, >6 months to ≤12 months, n=9
    7
        SID, >12 months to ≤24 months, n=4
    4
        SITL, ≥2 months to ≤6 months, n=1
    1
        SITL, >6 months to ≤12 months, n=2
    2
        SITL, >12 months to ≤24 months, n=6
    6
    Notes
    [3] - ITTC Population. Participants who were clinical successes are shown (n=X in category title).
    No statistical analyses for this end point

    Secondary: Bacteriological Success Rate at Follow-up, by Baseline Pathogen

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    End point title
    		 Bacteriological Success Rate at Follow-up, by Baseline Pathogen
    End point description
    Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as "n" in the category title) for each respective category is shown. ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline.
    End point type
    Secondary
    End point timeframe
    Follow-up, Days 12 to 16
    End point values
    		 Retapamulin Ointment, 1%
    Number of subjects analysed
    61 [4]
    Units: Number of pathogens eradicated
        All Pathogens, n=93
    79
        Staphylococcus aureus (SA), n=44
    40
        Methicillin-resistant SA, n=3
    3
        Methicillin-susceptible SA, n=41
    37
        Mupirocin susceptible SA, n=44
    40
        Fuscidic acid-resistant SA, n=2
    2
        Fuscidic acid-susceptible SA, n=42
    38
        Streptococcus pyogenes, n=9
    9
        Other Gram (+) pathogens, n=11
    9
        Gram (-) pathogens, n=29
    21
    Notes
    [4] - ITTB Population. Participants with >1 pathogen may be represented in the table more than once.
    No statistical analyses for this end point

    Secondary: Number of participants by age with therapeutic response of success

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    End point title
    		 Number of participants by age with therapeutic response of success
    End point description
    Therapeutic response is a measure of the overall efficacy response; a response of "therapeutic success" was based on both clinical success and bacteriological success in a given participant. ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population.
    End point type
    Secondary
    End point timeframe
    Follow-up, Days 12 to 16
    End point values
    		 Retapamulin Ointment, 1%
    Number of subjects analysed
    61 [5]
    Units: participants
        All ages
    51
        >2 months to <=6 months, n=21
    15
        >6 months to <=12 months, n=20
    17
        >12 months to <=24 months, n=20
    19
    Notes
    [5] - The number of participants who were therapeutic successes is shown (n=X in category titles).
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious AEs were collected throughout the course of the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Retapamulin Ointment, 1%
    Reporting group description
    		 Retapamulin ointment, 1%, administered twice daily for 5 consecutive days

    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 non-serious adverse events occurred at or above the specified 5% reporting threshold.
    Serious adverse events
    		 Retapamulin Ointment, 1%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 86 (1.16%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Retapamulin Ointment, 1%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 86 (0.00%)

    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? No

    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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