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Trial registered on ANZCTR


Registration number
ACTRN12616000356460
Ethics application status
Approved
Date submitted
10/03/2016
Date registered
18/03/2016
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the Old with the New: Randomised controlled trial of three different treatments for mild to moderate impetigo in children
Scientific title
Randomised controlled trial assessing the efficacy of topical fusidic acid and topical hydrogen peroxide cream for mild impetigo in school children.
Secondary ID [1] 288728 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impetigo 297969 0
Condition category
Condition code
Infection 298126 298126 0 0
Other infectious diseases
Skin 298159 298159 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be randomised between 3 possible interventions described below; children with 3 or less impetigo lesions will be enrolled and all lesions will be managed

1. Topical fusidic acid ointment 2% twice a day for 5 days - Fusidic acid 2% ointment (15g tube supplied) with single occasion wound cleaning by a nurse and topical fusidic acid ointment applied to each lesion then covered with occlusive dressing. Ongoing twice daily ointment and dressings twice daily will be done by parent/carer with instructions supplied with no adherence monitoring other than verbal review with nurse on Day 2 and day 7

Intervention 2. Topical hydrogen peroxide 1% (10g tube) applied twice a day for 5 days. Initial wound cleaning by nurse and H2O2 cream applied to each lesion then covered with an occlusive dressing. The topical antiseptic and sufficient dressings will be supplied to the family along with instructions with no adherence monitoring other than verbal review with nurse on Day 2 and day 7

Intervention 3: Wound care: the wound will be cleansed, scab softened and removed where possible, then covered with an occlusive dressing. Sufficient dressings will be supplied to the family along with instructions to cleanse and reapply dressing twice a day for 5 days with no adherence monitoring other than verbal review with nurse on Day 2 and day 7.

Assessment of lesions will be done ongoing at day 2 and day 7 after enrollment
Intervention code [1] 294166 0
Treatment: Drugs
Comparator / control treatment
Simple wound care: the wound will be cleansed, scab softened and removed where possible, then covered with an occlusive dressing. Sufficient dressings will be supplied to the family along with instructions to cleanse and reapply dressing twice a day for 5 days.
Control group
Active

Outcomes
Primary outcome [1] 297631 0
The primary outcome is treatment success as evaluated by review of digital images on day 0-7.
Independent reviewers (clinician including paediatrician x4, dermatologist x2) masked to treatment allocation will compare digital images of skin lesions from days 0 and 7. The order of the images when reviewed will be randomly assigned to ensure further blinding. Outcomes will be scored as success if they have healed or improved and failure if same or worse, or if the reviewer was unable to determine success or failure compared to day 0. Assessment criteria will be adapted from trial and methodology published by Bowen et al. Lancet ID 2014 Dec 13;384(9960):2132-40.
Timepoint [1] 297631 0
Primary time endpoint is outcome at Day 7
Digital images of skin lesions will be taken on Days 0 and 7
Secondary outcome [1] 321646 0
Secondary outcome
Number of treatment failures on both Day 2 and Day 7
This includes children assessed as needing change management of lesions such as escalation to oral antibiotics, visiting their general practitioner for concerns over the skin infection, or admission to hospital or medical review.

.

Timepoint [1] 321646 0
Treatment failures will be assessed by clinical review at day 2 and day 7 post treatment commencement by school/study nurse.
Secondary outcome [2] 321863 0
Clinical success at Day 7 based on nurse assessment using clinical notes, lesion size, patient report and clinical nursing assessment
Timepoint [2] 321863 0
Clinical success will be assessed by clinical review (at day 2) and day 7 post treatment commencement by school/study nurse.
Secondary outcome [3] 321864 0
Secondary outcome microbiologic based on detection of skin pathogens at Day 0 and Day 7 and comparison of antibiograms of isolated S.aureus and S.pyogenes from skin swabs
Timepoint [3] 321864 0
Swabs and cultured Day 0 and Day 7 of a single lesion

Eligibility
Key inclusion criteria
Consented children aged 5-13 years presenting with primary non-bullous impetigo in participating schools who currently are part of sore throat national programme to prevent rheumatic fever and have on site school nurses for this programme.
Minimum age
5 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Immunocompromised, extensive lesions (>3) requiring oral antibiotics at presentation, known allergy to study drugs, cellulitis, temperature >38.5 C, patients who had used topical or oral antibiotics in the previous 5 days, and patients for whom informed consent is not obtained. T

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone and computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using computer generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
non inferiority
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
To show no difference between treatment regimens and a predicted fusidic acid efficacy of 75% (as per previous published trials)we calculated that 160 participants per group are required: 480 children in total
This would provide 80% power and a one-sided a=0.05 to show non-inferiority (10% margin) between the groups

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7664 0
New Zealand
State/province [1] 7664 0

Funding & Sponsors
Funding source category [1] 293080 0
Charities/Societies/Foundations
Name [1] 293080 0
Cure Kids
Address [1] 293080 0
PO Box 90 907
Victoria Street West
Auckland 1142
Country [1] 293080 0
New Zealand
Primary sponsor type
Individual
Name
Dr Alison Leversha
Address
Community Child Health and Disability Services
Starship Children’s Health
2 Park Road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 291865 0
Other Collaborative groups
Name [1] 291865 0
NZ Wound Care Society
Address [1] 291865 0
Contact via Administrator
74 Fergusson Road, RD9
Fielding
4779
New Zealand
Country [1] 291865 0
New Zealand
Secondary sponsor category [2] 301397 0
Charities/Societies/Foundations
Name [2] 301397 0
A+ Trust
Address [2] 301397 0
ADHB Research Office,
Level 14, Support Building
Auckland City Hospital
Grafton
Auckland 1023
Country [2] 301397 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294590 0
Health and Disability Ethics committee
Ethics committee address [1] 294590 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 294590 0
New Zealand
Date submitted for ethics approval [1] 294590 0
21/03/2016
Approval date [1] 294590 0
26/10/2016
Ethics approval number [1] 294590 0
16/NTA/113

Summary
Brief summary
Skin sepsis is a common problem among children and severe skin infections are the most common reason for hospitalisation in NZ children. Pacific and Maori children are more likely to develop cellulitis than their NZ European counterparts and hospital admissions for skin sepsis occur at more than twice the rate in NZ compared with other developed countries. Evidence-based clinical guidelines for the treatment of mild to moderate impetigo recommend the use of fusidic acid cream, currently funded topical antimicrobial in NZ. Recent data, however, have identified a high rate of community resistance to this medication amongst Staphylococcus aureus (SA) ; resistance >30%. This is linked to widespread community use of this topical antibiotic. The evidence base for alternative treatment strategies for mild impetigo is limited and judicious use of topical antibacterials is needed. Alternative therapies must be urgently found to prevent increasing resistance.
The overall aim of the research is to compare two alternative treatments with the current standard of care treatment for mild-to-moderate impetigo among school children.
Aims To undertake a non-inferiority trial comparing topical fusidic acid with (i) topical hydrogen peroxide, and (ii) with simple wound care in a community with both high rates of impetigo and increasing fusidic acid resistance.
The results of this trial will inform evidence-based skin infection guidelines locally, nationally, and internationally including funding of best treatments.
Trial website
none
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 64286 0
Dr Alison Leversha
Address 64286 0
Community Child Health and Disability Services
Starship Children’s Health
Park Road Grafton
Auckland 1023


Country 64286 0
New Zealand
Phone 64286 0
+64 9 307 4949
Fax 64286 0
Email 64286 0
aleversha@adhb.govt.nz
Contact person for public queries
Name 64287 0
Dr Alison Leversha
Address 64287 0
Community Child Health and Disability Services
Starship Children’s Health
Park Road Grafton
Auckland 1023
Country 64287 0
New Zealand
Phone 64287 0
+64 9 307 4949
Fax 64287 0
Email 64287 0
aleversha@adhb.govt.nz
Contact person for scientific queries
Name 64288 0
Dr Alison Leversha
Address 64288 0
Community Child Health and Disability Services
Starship Children’s Health
Park Road Grafton
Auckland 1023
Country 64288 0
New Zealand
Phone 64288 0
+ 64 9 3074949
Fax 64288 0
Email 64288 0
aleversha@adhb.govt.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Indvidual anonymised data on primary outcome and microbiology
When will data be available (start and end dates)?
Approximately Jan 2020- Jan 2025
Available to whom?
Researchers in relevant fields
Available for what types of analyses?
To be discussed
How or where can data be obtained?
On request to Primary named researcher
What supporting documents are/will be available?
No other documents available
Summary results
No Results