Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

Status: Not yet recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3

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.

Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: No

• 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

Other Locations
The Tamaika Project
Contact Information
Catherine E Oldenburg, ScD
Hadley R Burroughs, MSPH
Time Frame
Start Date: November 1, 2022
Estimated Completion Date: November 1, 2025
Target number of participants: 600
Experimental: Azithromycin
Children in this arm will receive one dose of amoxicillin.
Active Comparator: Amoxicillin
Children in this arm will receive a 5-day course of amoxicillin (standard care).
Kieran S O'Brien
Related Therapeutic Areas
Collaborators: The Taimaka Project
Leads: University of California, San Francisco

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