ooking for better treatments for impetigo in Aboriginal childre

Phase 3

Completed

• Conditions: Impetigo in Aboriginal children; Skin - Other skin conditions; Infection - Other infectious diseases

• Registration Number: ACTRN12609000858291
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1. Age 12 weeks to less than 13 years at the time written consent is obtained
2. Diagnosis of purulent or crusted impetigo by criteria outlined in the Booklet Recognising and Treating Skin Conditions” (East Arnhem Healthy Skin Program (EAHSP), Menzies School of Health Research 2006).
3. A resident in one of the participating communities at the time of enrolment and intending to stay in that community for the duration of the study (7 days post randomisation).

Exclusion Criteria

1. Receipt of any antibiotic in the previous seven days, or receipt of benzathine penicillin G (BPG) in the previous 30 days. 2. The presence of impetigo lesions that are only flat-dry” (i.e. lesions that are not purulent or crusted) by criteria outlined in the Booklet Recognising and Treating Skin Conditions” (EAHSP, Menzies School of Health Research 2006). 3. Known allergy to penicillin, sulphonamides or trimethoprim, or other constituents of study medications. 4. Immunocompromised, that is acquired, congenital or iatrogenic. 5. Previous participation in the trial in the last 90 days. 6. Evidence of sepsis, cellulitis, bullous impetigo, boils or carbuncles. 7. Intention by the patient or parent to use topical antibiotics. 8. Any condition that the principal investigator considers warrants exclusion from the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of children successfully treated on day 7 after the commencement of treatment within each of the respective groups.<br>Successfully treated is defined as a child with impetigo which has been clinically classified as sore either healed or improved by a person blinded to the allocated randomisation.[Day 7 after the commencement of treatment]