NCT05473234

Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Acute Malnutrition

Interventions

Type	Name	Description
DRUG	Azithromycin	Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
DRUG	Amoxicillin	Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF.

Timeline

• Start date: 2022-10-06
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2022-07-25
• Last updated: 2025-02-25
• Results posted: 2025-02-25

Locations

1 site across 1 country: Nigeria

Regulatory

• FDA-regulated drug study