Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
Status:
Not yet recruiting
Trial end date:
2028-07-01
Target enrollment:
Participant gender:
Summary
Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for
the treatment of uncomplicated severe acute malnutrition (SAM). Because children with
uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive
treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing
infection and improving outcomes. Two randomized placebo-controlled randomized trials have
evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results
may indicate either that antibiotics are not helpful for the management of uncomplicated SAM,
or that a better antibiotic is needed. Recently, the investigators demonstrated that biannual
mass azithromycin distribution as a single oral dose reduces all-cause child mortality in
sub-Saharan Africa. Children with uncomplicated SAM, who have an elevated risk of mortality
relative to their well-nourished peers, may particularly benefit from presumptive
azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of
children with uncomplicated SAM in our study area, and showed no significant difference
between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here,
the investigators propose an individually randomized trial in which children will be
randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences
in weight gain, nutritional recovery, and the gut microbiome. The results of this study will
strengthen the evidence base for policy related to the use of antibiotics as part of the
management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo
as well as evaluation of an antibiotic class that has not been considered for uncomplicated
SAM, which may lead to changes in guidelines for treatment.
Phase:
Phase 4
Details
Lead Sponsor:
University of California, San Francisco
Collaborator:
Centre de Recherche en Sante de Nouna, Burkina Faso