Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: The Taimaka Project
• Treatments: Amoxicillin; Azithromycin

Criteria

Inclusion criteria (all must be met):

• Age 6-59 months

• Weight-for-height z-score (WHZ) < -3 SD or mid-upper arm circumference (MUAC) < 115 mm

• No nutritional or nutritional edema Grade I and II

• Primary residence within catchment area of enrollment site

• Available for full 8-week study

• Has not been admitted to a nutritional program for the treatment of severe acute malnutrition (SAM) in the 2 preceding weeks

• No antibiotic use in past 7 days

• No clinical complications requiring antibiotic treatment

• No clinical complications requiring inpatient treatment

• No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, sickle cell disease, etc)

• No allergy to macrolides/azalides

• Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)

• Appropriate written informed consent from at least one parent or guardian

Exclusion criteria (any excludes):

• Age < 6 months or > 59 months

• WHZ ≥ -3 SD or MUAC ≥ 115 mm

• Primary residence outside catchment area of enrollment site

• Not available for full 8-week study

• Presence of nutritional edema Grade III

• Admission to a nutritional program for the treatment of SAM in the 2 preceding weeks

• Antibiotic use in past 7 days

• Clinical complications requiring antibiotic treatment

• Clinical complications requiring inpatient treatment

• Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)

• Allergy to macrolides/azalides

• Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)

• Parent or guardian refuses to provide consent