Comparing the Old with the New: Randomised controlled trial of three different treatments for mild to moderate impetigo in childre

Phase 4

Recruiting

• Conditions: Impetigo; Infection - Other infectious diseases; Skin - Dermatological conditions

• Registration Number: ACTRN12616000356460
• Lead Sponsor: Dr Alison Leversha

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 480

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is treatment success as evaluated by review of digital images on day 0-7. <br>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. <br>[Primary time endpoint is outcome at Day 7 <br>Digital images of skin lesions will be taken on Days 0 and 7]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome<br>Number of treatment failures on both Day 2 and Day 7 <br>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.<br><br>. <br><br>[Treatment failures will be assessed by clinical review at day 2 and day 7 post treatment commencement by school/study nurse. <br>];Clinical success at Day 7 based on nurse assessment using clinical notes, lesion size, patient report and clinical nursing assessment[Clinical success will be assessed by clinical review (at day 2) and day 7 post treatment commencement by school/study nurse. ];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[Swabs and cultured Day 0 and Day 7 of a single lesion]