Looking for better treatments for impetigo in Aboriginal children

An open label randomised controlled trial to determine if 5 days of once-daily oral trimethoprim-sulfamethoxazole or three days of twice-daily oral trimethoprim-sulfamethoxazole will lead to non-inferior cure rates of impetigo compared to a single dose of intramuscular benzathine penicillin G (the current gold standard treatment) in children living in remote Aboriginal communities between the age of 12 weeks to less than 13 years.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000858291

Enrollment

663

Registered

2009-10-01

Start date

2009-11-26

Completion date

2012-11-20

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to conduct a randomised controlled trial to determine the efficacy of two oral regimens of trimethoprim-sulfamethoxazole compared to benzathine penicillin (BPG), for the treatment of skin sores (also known as impetigo) in Aboriginal children living in remote communities. Trimethoprim-sulfamethoxazole may be a much more acceptable oral alternative compared to the uncomfortable and poorly received intramuscular benzathine penicillin which is the current standard of care.

Interventions

Arm 2: Trimethoprim-sulfamethoxazole oral suspension 8 + 40 mg/kg (max 320 + 1600 mg) daily for 5 days Arm 3: Trimethoprim-sulfamethoxazole oral suspension 4 + 20 mg/kg (max 160 + 800 mg) twice daily for three days

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

12 Weeks to 13 Years

Healthy volunteers

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.

Outcome results