Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
Summary
This randomized controlled trial is designed to determine the effect of administration of
azithromycin compared to amoxicillin as part of the treatment of uncomplicated severe acute
malnutrition (SAM) in children aged 6-59 months on weight gain and nutritional recovery. The
investigators will randomize children presenting to Taimaka-run nutritional programs at
health centers in Gombe State, Nigeria to a single dose of oral azithromycin or a short
course of oral amoxicillin upon admission into the program. Apart from the administration of
antibiotics, all children will receive standard outpatient treatment for uncomplicated SAM as
specified in the guidelines of the government of Nigeria, which includes therapeutic feeding
with ready-to-use therapeutic food (RUTF). Enrolled children will be followed weekly at each
routine clinic follow-up visit up until nutritional recovery. All enrolled children will
return for a final study visit at 8 weeks following enrollment. Anthropometric and vital
status data will be collected at each follow-up visit. Weight gain and nutritional recovery
over the 8-week study period will be compared by arm as a primary outcome and at 12 weeks as
a secondary outcome.