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    Clinical Trial Results:
    A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study

    Summary
    EudraCT number
    		 2011-003591-37
    Trial protocol
    		 GB  
    Global end of trial date
    25 Mar 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 Mar 2019
    First version publication date
    23 Jul 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Inconsistency in closure date - needed updating
    Summary report(s)
    		 CREAM: NIHr HTA final report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SPON846-10
    Additional study identifiers
    ISRCTN number
    		 ISRCTN96705420
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cardiff University
    Sponsor organisation address
    McKensie House, Newport Road, Cardiff, United Kingdom, CF24 0DE
    Public contact
    Trial Manager, Cardiff University, 44 02920687620, CREAM@cardiff.ac.uk
    Scientific contact
    Trial Manager, Cardiff University, 44 02920687665, CREAM@cardiff.ac.uk
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Does the addition of oral or topical antibiotic treatment to treatment with corticosteroid cream, reduce eczema severity in children with suspected infected eczema in primary care?
    Protection of trial subjects
    The IDMC for the CREAM trial was build-up to safeguard the interests of the CREAM trial participants, potential participants, investigator and sponsor; to assess the safety and efficacy of the trial interventions, and to monitor the trial's overall conduct, and protect its validity and credibility. Three IDMC meetings had been held (12th March 2012, 04th November 2013 and 07th May 2014). The IDMC received and reviewed the progress and accruing data of this trial and provided advice on the conduct of the trial to the Trial Steering Committee (TSC).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jul 2013
    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 Kingdom: 113
    Worldwide total number of subjects
    113
    EEA total number of subjects
    113
    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)
    45
    Children (2-11 years)
    68
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 General practitioner practices and dermatology clinic sites were recruited between 9 July 2013 and 21 October 2014. 32 GP sites and 1 dermatology clinic actively recruited one or more participants into the study. Participants were recruited between 16 July 2013 and 28 November 2014. Of the 171 referred children, 113 were randomized.

    Pre-assignment
    Screening details
    		 1. Eligible patients identified by general practices and secondary care centres. 2. Research nurse checks eligibility. 3. Pharmacy randomises and dispenses medicine to research nurse

    Pre-assignment period milestones
    Number of subjects started
    		 171 [1]
    Number of subjects completed
    		 113

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Ineligible: 18
    Reason: Number of subjects
    		 Unable to participate because of time/resources: 28
    Reason: Number of subjects
    		 Declined to participate: 12
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number reported in the pre-assignment period include all participants screened for the study (171 in total). Enrolled and consented total = 113. 58 participants were either ineligible or declined to participate.
    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor
    Blinding implementation details
    Placebo products were matched to oral and topical antibiotic preparations. Participants, parents, clinicians and research nurses remained blinded to treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control_baseline
    Arm description
    		 placebo oral and placebo topical cream treatment at baseline
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Arm title
    		 Oral antibiotic_baseline
    Arm description
    		 oral antibiotic and placebo topical cream at baseline
    Arm type
    		 Experimental

    Investigational medicinal product name
    flucloxacillin
    Investigational medicinal product code
    PL 20416/0077
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    granules for reconstitution in 100 ml to provide a concentration of 250 mg/5 ml. the usual doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Arm title
    		 Topical antibiotic_baseline
    Arm description
    		 topical antibiotic cream and placebo oral treatment at baseline
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Investigational medicinal product name
    Fuscidic acid cream 2%
    Investigational medicinal product code
    PL 00043/0065
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    apply topical cream medicine 3 times a day for 1 week

    Number of subjects in period 1
    		Control_baseline Oral antibiotic_baseline Topical antibiotic_baseline
    Started
    40
    36
    37
    Completed
    40
    36
    37
    Period 2
    Period 2 title
    2-week follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control_week2
    Arm description
    		 placebo oral and placebo topical cream treatment at week2
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Arm title
    		 Oral antibiotic_week2
    Arm description
    		 oral antibiotic and placebo topical cream at week-2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Investigational medicinal product name
    flucloxacillin
    Investigational medicinal product code
    PL 20416/0077
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    granules for reconstitution in 100 ml to provide a concentration of 250 mg/5 ml. the usual doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Arm title
    		 Topical antibiotic_week2
    Arm description
    		 topical antibiotic cream and placebo oral treatment at week-2
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fuscidic acid cream 2%
    Investigational medicinal product code
    PL 00043/0065
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    apply topical cream medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Number of subjects in period 2
    		Control_week2 Oral antibiotic_week2 Topical antibiotic_week2
    Started
    40
    36
    37
    Completed
    36
    34
    31
    Not completed
    4
    2
    6
         Consent withdrawn by subject
    2
    1
    5
         Lost to follow-up
    2
    1
    1
    Period 3
    Period 3 title
    4-week follow up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control_week4
    Arm description
    		 placebo oral and placebo topical cream treatment at week-4
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Arm title
    		 Oral antibiotic_week4
    Arm description
    		 oral antibiotic and placebo topical cream at week-4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Investigational medicinal product name
    flucloxacillin
    Investigational medicinal product code
    PL 20416/0077
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    granules for reconstitution in 100 ml to provide a concentration of 250 mg/5 ml. the usual doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Arm title
    		 Topical antibiotic_week4
    Arm description
    		 topical antibiotic cream and placebo oral treatment at week-4
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fuscidic acid cream 2%
    Investigational medicinal product code
    PL 00043/0065
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    apply topical cream medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Number of subjects in period 3
    		Control_week4 Oral antibiotic_week4 Topical antibiotic_week4
    Started
    36
    34
    31
    Completed
    35
    33
    30
    Not completed
    1
    1
    1
         Consent withdrawn by subject
    1
    -
    -
         Lost to follow-up
    -
    1
    1
    Period 4
    Period 4 title
    3-month follow up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control_month3
    Arm description
    		 placebo oral and placebo topical cream treatment at month-3
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Arm title
    		 Oral antibiotic_month3
    Arm description
    		 oral antibiotic and placebo topical cream at month-3
    Arm type
    		 Experimental

    Investigational medicinal product name
    flucloxacillin
    Investigational medicinal product code
    PL 20416/0077
    Other name
    Pharmaceutical forms
    Concentrate for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    granules for reconstitution in 100 ml to provide a concentration of 250 mg/5 ml. the usual doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Investigational medicinal product name
    Placebo topical cream
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The placebo antibiotic cream used in this study was manufactured to match the active treatment. Apply medicine 3 times a day for 1 week

    Arm title
    		 Topical antibiotic_month3
    Arm description
    		 topical antibiotic cream and placebo oral treatment at month-3
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fuscidic acid cream 2%
    Investigational medicinal product code
    PL 00043/0065
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    apply topical cream medicine 3 times a day for 1 week

    Investigational medicinal product name
    Placebo oral solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    supplied as granules for reconstitution doses for each age group are - • Children (2-5 years of age): 5ml four times a day • Children under 2 years of age: 2.5ml four times a day

    Number of subjects in period 4
    		Control_month3 Oral antibiotic_month3 Topical antibiotic_month3
    Started
    35
    33
    30
    Completed
    25
    28
    21
    Not completed
    10
    5
    9
         Lost to follow-up
    10
    5
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control_baseline
    Reporting group description
    		 placebo oral and placebo topical cream treatment at baseline

    Reporting group title
    Oral antibiotic_baseline
    Reporting group description
    		 oral antibiotic and placebo topical cream at baseline

    Reporting group title
    Topical antibiotic_baseline
    Reporting group description
    		 topical antibiotic cream and placebo oral treatment at baseline

    Reporting group values
    		 Control_baseline Oral antibiotic_baseline Topical antibiotic_baseline Total
    Number of subjects
    		 40 36 37 113
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 15 15 15 45
        Children (2-11 years)
    		 25 21 22 68
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Age
    Units: years
        arithmetic mean (standard deviation)
    		 3.3 ( 2.2 ) 2.9 ( 2.2 ) 3 ( 2.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 18 17 52
        Male
    		 23 18 20 61
    Subject analysis sets

    Subject analysis set title
    analysis of primary outcome
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Our main (primary) analyses are intention-to-treat (ITT) analyses comparing POEM scores at 2 weeks in the oral antibiotic group with the control (placebo) group, and in the topical antibiotic group with the control (placebo) group, and using all participants who have baseline and 2-week POEM scores (i.e. not using imputation for the primary ITT analysis). This was conducted using the analysis of covariance (ANCOVA) approach, controlling for baseline POEM score.

    Subject analysis set title
    analysis of secondary outcomes
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The analysis of POEM scores at 4 weeks and 3 months, EASI scores at 2 and 4 weeks, IDQoL, CDLQI and DFI scores at 2 and 4 weeks and 3 months were also carried out using the ANCOVA approach. That is, we used these scores as dependent variables, controlling for baseline scores and treatment arms, where the placebo group was set as the reference category. As these scores (EASI, IDQoL, CDLQI and DFI) were positively skewed and contained a number of zeros, we took the natural log transformation of the scores plus one. Therefore, the results of these analyses are presented as the percentage differences of the scores between treatment groups.

    Subject analysis sets values
    		 analysis of primary outcome analysis of secondary outcomes
    Number of subjects
    113
    113
    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)
    45
    45
        Children (2-11 years)
    68
    68
        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
    Age
    Units: years
        arithmetic mean (standard deviation)
    3.1 ( 2.1 )
    3.1 ( 2.1 )
    Gender categorical
    Units: Subjects
        Female
    52
    52
        Male
    61
    61

    End points

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    End points reporting groups
    Reporting group title
    Control_baseline
    Reporting group description
    		 placebo oral and placebo topical cream treatment at baseline

    Reporting group title
    Oral antibiotic_baseline
    Reporting group description
    		 oral antibiotic and placebo topical cream at baseline

    Reporting group title
    Topical antibiotic_baseline
    Reporting group description
    		 topical antibiotic cream and placebo oral treatment at baseline
    Reporting group title
    Control_week2
    Reporting group description
    		 placebo oral and placebo topical cream treatment at week2

    Reporting group title
    Oral antibiotic_week2
    Reporting group description
    		 oral antibiotic and placebo topical cream at week-2

    Reporting group title
    Topical antibiotic_week2
    Reporting group description
    		 topical antibiotic cream and placebo oral treatment at week-2
    Reporting group title
    Control_week4
    Reporting group description
    		 placebo oral and placebo topical cream treatment at week-4

    Reporting group title
    Oral antibiotic_week4
    Reporting group description
    		 oral antibiotic and placebo topical cream at week-4

    Reporting group title
    Topical antibiotic_week4
    Reporting group description
    		 topical antibiotic cream and placebo oral treatment at week-4
    Reporting group title
    Control_month3
    Reporting group description
    		 placebo oral and placebo topical cream treatment at month-3

    Reporting group title
    Oral antibiotic_month3
    Reporting group description
    		 oral antibiotic and placebo topical cream at month-3

    Reporting group title
    Topical antibiotic_month3
    Reporting group description
    		 topical antibiotic cream and placebo oral treatment at month-3

    Subject analysis set title
    analysis of primary outcome
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Our main (primary) analyses are intention-to-treat (ITT) analyses comparing POEM scores at 2 weeks in the oral antibiotic group with the control (placebo) group, and in the topical antibiotic group with the control (placebo) group, and using all participants who have baseline and 2-week POEM scores (i.e. not using imputation for the primary ITT analysis). This was conducted using the analysis of covariance (ANCOVA) approach, controlling for baseline POEM score.

    Subject analysis set title
    analysis of secondary outcomes
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The analysis of POEM scores at 4 weeks and 3 months, EASI scores at 2 and 4 weeks, IDQoL, CDLQI and DFI scores at 2 and 4 weeks and 3 months were also carried out using the ANCOVA approach. That is, we used these scores as dependent variables, controlling for baseline scores and treatment arms, where the placebo group was set as the reference category. As these scores (EASI, IDQoL, CDLQI and DFI) were positively skewed and contained a number of zeros, we took the natural log transformation of the scores plus one. Therefore, the results of these analyses are presented as the percentage differences of the scores between treatment groups.

    Primary: POEM scores at 2-week

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    End point title
    		 POEM scores at 2-week
    End point description
    POEM scores can range from 0 to 28, and higher POEM scores represent worse eczema severity.
    End point type
    Primary
    End point timeframe
    At 2 weeks following the baseline visit research nurses recorded POEM.
    End point values
    		 Control_week2 Oral antibiotic_week2 Topical antibiotic_week2
    Number of subjects analysed
    36
    34
    31
    Units: Range from 0 to 28
        arithmetic mean (standard error)
    6.17 ( 5.97 )
    8.27 ( 7.33 )
    9.32 ( 6.17 )
    Statistical analysis title
    		 ANCOVA analysis of POEW at 2-week follow-up
    Statistical analysis description
    Our main (primary) analyses are intention-to-treat (ITT) analyses comparing POEM scores at 2 weeks in the oral antibiotic group with the control (placebo) group, and using all participants who have baseline and 2-week POEM scores (i.e. not using imputation for the primary ITT analysis). This was conducted using the analysis of covariance (ANCOVA) approach, controlling for baseline POEM score.
    Comparison groups
    Oral antibiotic_week2 v Control_week2
    Number of subjects included in analysis
    70
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.35
         upper limit
    		 4.4
    Notes
    [1] - Owing to lower than expected recruitment rates the study was closed early, before the proposed reduced target sample size was reached. Because of this, the analysis focuses on estimating effect sizes and confidence intervals (CIs) rather than tests of significance, which would have been undertaken if the sample size had been achieved.
    Statistical analysis title
    		 ANCOVA analysis of POEW at 2-week follow-up
    Statistical analysis description
    Our main (primary) analyses are intention-to-treat (ITT) analyses comparing POEM scores at 2 weeks in the topical antibiotic group with the control (placebo) group, and using all participants who have baseline and 2-week POEM scores (i.e. not using imputation for the primary ITT analysis). This was conducted using the analysis of covariance (ANCOVA) approach, controlling for baseline POEM score.
    Comparison groups
    Topical antibiotic_week2 v Control_week2
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.55
         upper limit
    		 4.53
    Notes
    [2] - Owing to lower than expected recruitment rates the study was closed early, before the proposed reduced target sample size was reached. Because of this, the analysis focuses on estimating effect sizes and confidence intervals (CIs) rather than tests of significance, which would have been undertaken if the sample size had been achieved.

    Secondary: POEM at 4-week follow-up

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    End point title
    		 POEM at 4-week follow-up
    End point description
    POEM scores can range from 0 to 28, and higher POEM scores represent worse eczema severity.
    End point type
    Secondary
    End point timeframe
    POEM score collect at week-4 follow up.
    End point values
    		 Control_week4 Oral antibiotic_week4 Topical antibiotic_week4
    Number of subjects analysed
    35
    33
    30
    Units: Range from 0 to 28
        arithmetic mean (standard deviation)
    8.03 ( 5.95 )
    8.36 ( 7.71 )
    9.53 ( 5.89 )
    No statistical analyses for this end point

    Secondary: POEM at 3-month follow up

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    End point title
    		 POEM at 3-month follow up
    End point description
    POEM scores can range from 0 to 28, and higher POEM scores represent worse eczema severity.
    End point type
    Secondary
    End point timeframe
    POEM scores collected at 3-month follow up.
    End point values
    		 Control_month3 Oral antibiotic_month3 Topical antibiotic_month3
    Number of subjects analysed
    25
    28
    21
    Units: Range from 0 to 28
        arithmetic mean (standard deviation)
    7.72 ( 5.52 )
    7.86 ( 6.09 )
    7.86 ( 5.85 )
    No statistical analyses for this end point

    Secondary: EASI at 2-week follow-up

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    End point title
    		 EASI at 2-week follow-up
    End point description
    EASI scores range from 0 to 72, and higher scores represent more severe eczema.
    End point type
    Secondary
    End point timeframe
    At 2 weeks following the baseline visit research nurses recorded EASI scores.
    End point values
    		 Control_week2 Oral antibiotic_week2 Topical antibiotic_week2
    Number of subjects analysed
    34
    34
    31
    Units: Range from 0 to 72
        arithmetic mean (standard deviation)
    2.5 ( 5.64 )
    3.09 ( 3.59 )
    4.91 ( 5.65 )
    No statistical analyses for this end point

    Secondary: EASI at week-4 follow up

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    End point title
    		 EASI at week-4 follow up
    End point description
    EASI scores range from 0 to 72, and higher scores represent more severe eczema.
    End point type
    Secondary
    End point timeframe
    At 4 weeks following the baseline visit research nurses recorded EASI scores.
    End point values
    		 Control_week4 Oral antibiotic_week4 Topical antibiotic_week4
    Number of subjects analysed
    34
    33
    30
    Units: Range from 0 to 72
        arithmetic mean (standard deviation)
    4.01 ( 6.55 )
    3.23 ( 3.81 )
    4.98 ( 6.87 )
    No statistical analyses for this end point

    Secondary: DFI at 2-week follow up

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    End point title
    		 DFI at 2-week follow up
    End point description
    Impact on the family was measured using the DFI instrument, which includes 10 items each scored from 0 to 3. This results in a score from 0 to 30, with higher scores representing more severe impact on the family.
    End point type
    Secondary
    End point timeframe
    DFI scores collected at week-2 follow-up.
    End point values
    		 Control_week2 Oral antibiotic_week2 Topical antibiotic_week2
    Number of subjects analysed
    35
    34
    31
    Units: Range from 0 to 30
        arithmetic mean (standard deviation)
    2.6 ( 4.76 )
    3.69 ( 4.42 )
    4.84 ( 5.35 )
    No statistical analyses for this end point

    Secondary: DFI at 4-week follow-up

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    End point title
    		 DFI at 4-week follow-up
    End point description
    Impact on the family was measured using the DFI instrument, which includes 10 items each scored from 0 to 3. This results in a score from 0 to 30, with higher scores representing more severe impact on the family.
    End point type
    Secondary
    End point timeframe
    DFI collected at week-4 follow-up.
    End point values
    		 Control_week4 Oral antibiotic_week4 Topical antibiotic_week4
    Number of subjects analysed
    35
    33
    30
    Units: Range from 0 to 30
        arithmetic mean (standard deviation)
    3.11 ( 4.86 )
    3.52 ( 4.6 )
    4.23 ( 4.83 )
    No statistical analyses for this end point

    Secondary: DFI at 3-month follow-up

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    End point title
    		 DFI at 3-month follow-up
    End point description
    Impact on the family was measured using the DFI instrument, which includes 10 items each scored from 0 to 3. This results in a score from 0 to 30, with higher scores representing more severe impact on the family.
    End point type
    Secondary
    End point timeframe
    DFI scores collected at 3-month follow up
    End point values
    		 Control_month3 Oral antibiotic_month3 Topical antibiotic_month3
    Number of subjects analysed
    24
    25
    20
    Units: Range form 0 to 30
        arithmetic mean (standard deviation)
    3.5 ( 4.28 )
    3.46 ( 4.4 )
    4.1 ( 5.52 )
    No statistical analyses for this end point

    Secondary: IDQoL at week-2 follow-up

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    End point title
    		 IDQoL at week-2 follow-up
    End point description
    IDQoL scores include 10 items and have scores that range from 0 to 30, where higher scores represent more severe (worse) impact on quality of life.
    End point type
    Secondary
    End point timeframe
    IDQoL scores for children under 4 years old collected at week-2 follow-up
    End point values
    		 Control_week2 Oral antibiotic_week2 Topical antibiotic_week2
    Number of subjects analysed
    20
    25
    22
    Units: Range from 0 to 30
        arithmetic mean (standard deviation)
    6.07 ( 3.69 )
    6.74 ( 3.28 )
    7.19 ( 3 )
    No statistical analyses for this end point

    Secondary: IDQoL scores at week-4 follow-up

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    End point title
    		 IDQoL scores at week-4 follow-up
    End point description
    IDQoL scores include 10 items and have scores that range from 0 to 30, where higher scores represent more severe (worse) impact on quality of life.
    End point type
    Secondary
    End point timeframe
    IDQoL scores for children under 4 years old collected at week-4 follow-up
    End point values
    		 Control_week4 Oral antibiotic_week4 Topical antibiotic_week4
    Number of subjects analysed
    20
    24
    22
    Units: Range from 0 to 30
        arithmetic mean (standard deviation)
    6.92 ( 3.74 )
    6.59 ( 3.23 )
    7.14 ( 2.96 )
    No statistical analyses for this end point

    Secondary: IDQoL scores at month-3 follow-up

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    End point title
    		 IDQoL scores at month-3 follow-up
    End point description
    IDQoL scores include 10 items and have scores that range from 0 to 30, where higher scores represent more severe (worse) impact on quality of life.
    End point type
    Secondary
    End point timeframe
    IDQoL scores for children under 4 years old collected at month-3 follow-up
    End point values
    		 Control_month3 Oral antibiotic_month3 Topical antibiotic_month3
    Number of subjects analysed
    16
    18
    15
    Units: Range from 0-30
        arithmetic mean (standard deviation)
    7.25 ( 2.59 )
    6.01 ( 3.15 )
    6.67 ( 3.5 )
    No statistical analyses for this end point

    Secondary: CDLQI at week-2 follow up

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    End point title
    		 CDLQI at week-2 follow up
    End point description
    CDLQI scores include 10 items and have scores that range from 0 to 30, where higher scores represent more severe (worse) impact on quality of life.
    End point type
    Secondary
    End point timeframe
    CDLQI scores for children over 4 years old collected at week-2 follow-up
    End point values
    		 Control_week2 Oral antibiotic_week2 Topical antibiotic_week2
    Number of subjects analysed
    14
    9
    9
    Units: Range from 0-30
        arithmetic mean (standard deviation)
    1.82 ( 1.98 )
    4.07 ( 3.04 )
    5.88 ( 6.25 )
    No statistical analyses for this end point

    Secondary: CDLQI scores at week-4 follow-up

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    End point title
    		 CDLQI scores at week-4 follow-up
    End point description
    CDLQI scores include 10 items and have scores that range from 0 to 30, where higher scores represent more severe (worse) impact on quality of life.
    End point type
    Secondary
    End point timeframe
    CDLQI scores for children over 4 years old collected at week-2 follow-up
    End point values
    		 Control_week4 Oral antibiotic_week4 Topical antibiotic_week4
    Number of subjects analysed
    14
    9
    8
    Units: Range from 0-30
        arithmetic mean (standard deviation)
    4.64 ( 5.89 )
    4.36 ( 4.79 )
    3.04 ( 2.22 )
    No statistical analyses for this end point

    Secondary: CDLQI scores at month-3 follow-up

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    End point title
    		 CDLQI scores at month-3 follow-up
    End point description
    CDLQI scores include 10 items and have scores that range from 0 to 30, where higher scores represent more severe (worse) impact on quality of life.
    End point type
    Secondary
    End point timeframe
    CDLQI scores for children over 4 years old collected at month-3 follow-up
    End point values
    		 Control_month3 Oral antibiotic_month3 Topical antibiotic_month3
    Number of subjects analysed
    8
    6
    6
    Units: Range from 0 to 30
        arithmetic mean (standard deviation)
    6.18 ( 6.37 )
    5.57 ( 6.73 )
    4.61 ( 4.59 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Data on adverse effects were obtained from the daily symptom diaries and were available the first 4 weeks after enrollment. The daily symptom diary included potential adverse effects, with each symptom being rated from 0 to 6 by parents.
    Adverse event reporting additional description
    In order to capture potential adverse effects related to treatment , we included the treatment period (the first 7 days) and the subsequent 2 days (i.e. the first 9 days). Patients were categorised as having that adverse event if any potential adverse symptom was rated as a ‘slight problem’ or worse (i.e. score of ≥ 2) in any of the first 9 days.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Symptoms diary
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 placebo oral and placebo topical cream treatment

    Reporting group title
    Oral antibiotic
    Reporting group description
    		 oral antibiotic and placebo topical cream

    Reporting group title
    Topical antibiotic
    Reporting group description
    		 topical antibiotic cream and placebo oral treatment

    Serious adverse events
    		 Control Oral antibiotic Topical antibiotic
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 33 (0.00%)
    0 / 29 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Oral antibiotic Topical antibiotic
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 35 (37.14%)
    10 / 33 (30.30%)
    11 / 29 (37.93%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 33 (6.06%)
    1 / 29 (3.45%)
         occurrences all number
    3
    2
    1
    Vomiting
         subjects affected / exposed
    6 / 35 (17.14%)
    4 / 33 (12.12%)
    2 / 29 (6.90%)
         occurrences all number
    6
    4
    2
    Diarrhoea
         subjects affected / exposed
    5 / 35 (14.29%)
    5 / 33 (15.15%)
    5 / 29 (17.24%)
         occurrences all number
    5
    5
    5
    Tummy Pain
         subjects affected / exposed
    2 / 35 (5.71%)
    3 / 33 (9.09%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    3
    Skin and subcutaneous tissue disorders
    New rash
         subjects affected / exposed
    8 / 35 (22.86%)
    4 / 33 (12.12%)
    5 / 29 (17.24%)
         occurrences all number
    8
    4
    5
    Musculoskeletal and connective tissue disorders
    Joint Pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 33 (3.03%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2013
    Update all aspects of the protocol to clarify changes to data collection: o photographs will no longer be taken at the baseline visit. o The week 1 visit will be stopped. Study Trial Packs (medication) will be collected at week 2 visit.  Inclusion and exclusion criteria updated.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28289111
    For support, Contact us.
    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
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