Cotrimoxazole Prophylaxis in Severely Malnourished Children
Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
Participant gender:
Summary
This trial aims to test the hypothesis that mortality among Kenyan children with severe
malnutrition following initial stabilisation is due to ongoing vulnerability to infectious
disease, and that long term daily co-trimoxazole prophylaxis will reduce mortality.
The objective is to conduct a randomized, double blind, placebo-controlled trial of
cotrimoxazole prophylaxis for 6 months among HIV-uninfected children with severe malnutrition
following stabilization. The primary outcome will be survival at one year. Secondary outcomes
are toxicity, growth, the frequency and causes of hospitalisation and microbial resistance to
antibiotics.
Cotrimoxazole has striking protective efficacy against mortality among children with HIV,
despite not altering the underlying immune deficiency. It is hypothesised that co-trimoxazole
prophylaxis will have a similar effect in children immunocompromised because of severe
malnutrition. Worldwide, severe malnutrition is commoner than HIV in childhood and
co-trimoxazole is cheap and widely available, making it easily translatable to policy.