Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Status:
Completed
Trial end date:
2020-12-25
Target enrollment:
Participant gender:
Summary
This pilot study is a randomized controlled trial designed to test the effect of the
administration of adjunctive azithromycin in conjunction with standard outpatient treatment
for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children
presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be
randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard
of care) upon admission into the program. All enrolled children will receive ready-to-use
therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up
visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and
adverse events will be collected during follow-up. Nutritional recovery over the 8-week study
period will be compared by arm.
Phase:
Phase 3
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Centre de Recherche en Sante de Nouna, Burkina Faso Centre de Recherche et Interventions en Sante Publique (CRISP) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Francis I. Proctor Foundation, University of California, San Francisco