Is cotrimoxazole safe and efficacious for treatment of skin sores in Aboriginal children: a pilot study

In Aboriginal children in remote communities, is oral cotrimoxazole as safe and efficacious as intramuscular benzathine penicillin, in achieving resolution of skin sores?

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000592448

Enrollment

Registered

2007-11-19

Start date

2008-01-01

Completion date

Unknown

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 pilot study to determine the efficacy and safety of oral cotrimoxazole compared to benzathine penicillin (BPG), for the treatment of skin sores(also known as impetigo) in children living in a remote Aboriginal community in the Northern Territory. Cotrimoxazole 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

Oral cotrimoxazole 4+20 mg/kg (up to 160/800mg) twice daily for 5 days

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

2 Months to 16 Years

Healthy volunteers

Inclusion criteria

Diagnosis of purulent or crusted impetigo.

Exclusion criteria

1. Receipt of any antibiotic in the previous seven days, or receipt of benzathine penicillin 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) 3. Known allergy to penicillin, sulphonamide drugs or trimethoprim, or other constituents of study medications. 4. Immunocompromised. 5. Acute or chronic dermatosis. 6. Evidence of sepsis, cellulitis, bullous impetigo, boils or carbuncles.

Outcome results