Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

Phase 3

Terminated

• Conditions: Severe Acute Malnutrition
• Interventions: Drug: Amoxicillin; Drug: Azithromycin

• Registration Number: NCT05473234
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-25
• Study Start: 2022-10-06
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Results First Submitted: 2024-12-10
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Results First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin	Amoxicillin	Children in this arm will receive a 5-day course of amoxicillin (standard care).
Azithromycin	Azithromycin	Children in this arm will receive one dose of amoxicillin.

Primary Outcome Measures

Name	Time	Method
Weight Gain at 8 Weeks	8 weeks	Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Nutritional Recovery at 8 Weeks	8 weeks	Nutritional recovery will be defined as a child having WHZ ≥ -2 on two consecutive visits and no acute complication or edema for the past 7 days AND / OR MUAC of ≥ 125mm on 2 consecutive visits and no acute complication or edema for the past 7 days.; Children will be considered recovered or not recovered using these criteria; Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards; A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ \< -2 standard distributions below the median is defined as moderately wasted, while a WHZ \< -3 standard distributions below the median is defined as severely wasted.

Trial Locations

Locations (1)

The Tamaika Project; 🇳🇬 Gombe, Gombe State, Nigeria