CompletedPhase 3ACTRN12609000858291

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.

Sponsor

Menzies School of Health Research

Enrollment

660 participants

Start Date

Nov 26, 2009

Study Type

Interventional

Conditions

Impetigo in Aboriginal children

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.

Eligibility

Sex: Both males and femalesMin Age: 12 WeekssMax Age: 13 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares different antibiotic treatments for impetigo (a common skin infection) in Aboriginal children aged 12 weeks to 13 years in remote communities. It aims to find the most effective way to treat the skin sores that are common in these communities.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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

Locations(1)

NT, Australia

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ACTRN12609000858291