NCT05473234

Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

Terminated Phase 3 Results posted Last updated 25 February 2025

What this trial tests

Phase 3 trial testing Azithromycin in Severe Acute Malnutrition in 310 participants. Terminated before completion.

Timeline

6 October 2022

Primary endpoint
29 November 2023

29 November 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	310
Start date	6 October 2022
Primary completion	29 November 2023
Estimated completion	29 November 2023
Sites	1 location across Nigeria

Drugs / interventions tested

• Azithromycin (azithromycin) — full drug profile →
• Amoxicillin (amoxicillin) — full drug profile →

Conditions studied

• Severe Acute Malnutrition — all drugs for Severe Acute Malnutrition →

Sponsor

University of California, San Francisco

Who can join

Adults 6 Months to 59 Months, any sex, with Severe Acute Malnutrition. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weight Gain at 8 Weeks Primary · 8 weeks

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

Group	Value	95% CI
Amoxicillin	30.42	± 17.11
Azithromycin	27.75	± 18.82

Number of Participants With Nutritional Recovery at 8 Weeks Secondary · 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 be

Group	Value	95% CI
Amoxicillin	85
Azithromycin	105

Weight Gain Over 12 Weeks Secondary · 12 weeks

Weight will be measured at baseline and weekly follow up visits for 8 weeks, and at 12 weeks after admission to the program. Weight gain will be defined as grams per kilogram per day (g/day).

Group	Value	95% CI
Amoxicillin	22.67	± 13.13
Azithromycin	23.89	± 11.58

Time to Recovery Secondary · 12 weeks

Time from enrollment to nutritional recovery will be calculated in days by subtracting the date of enrollment from the date of nutritional recovery.

Group	Value	95% CI
Amoxicillin	21.4	± 19.2
Azithromycin	22.4	± 19.3

Nonresponse at 8 Weeks Secondary · 8 weeks

Number of children with nonresponse will be documented if a child does not meet the criteria for nutritional recovery at 8 weeks after enrollment.

Group	Value	95% CI
Amoxicillin	11
Azithromycin	15

Number of Participants Who Transferred to Inpatient Care Secondary · 12 weeks

The occurrence, date, and reason for transfer from outpatient to inpatient treatment will be recorded.

Group	Value	95% CI
Amoxicillin	3
Azithromycin	4

Mortality by 8 Weeks Secondary · 8 weeks

Vital status will be assessed at baseline and at weekly follow up visits for 8 weeks, and mortality will be defined as death during the study period. Date of death will be recorded.

Group	Value	95% CI
Amoxicillin	3
Azithromycin	2

Mortality by 12 Weeks Secondary · 12 weeks

Vital status will be assessed at baseline, weekly follow up visits for 8 weeks, and at 12 weeks, and mortality will be defined as death during the study period. Date of death will be recorded.

Group	Value	95% CI
Amoxicillin	4
Azithromycin	3

Clinical Signs of Infection Secondary · 12 weeks

Number of participants with clinical sign of infection will be recorded At baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit, including care-giver reported experience of fever, diarrhea, vomiting, and respiratory infection/cough and clinical diagnoses made at by site personnel

Group	Value	95% CI
Amoxicillin	6
Azithromycin	16

Height-for-age Z-score (HAZ) Secondary · 12 weeks

Height or length will be measured monthly (baseline and the 4-, 8-, and 12-week follow up visits) and height-for-age z-scores will be calculated. 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 HAZ \< -2 standard distributions below the median is defined as stunted, while a HAZ \< -3 standard distributions below the median is defined as severely stunted.

Group	Value	95% CI
Amoxicillin	-3.77	± 1.98
Azithromycin	-3.64	± 1.49

Mid-upper Arm Circumference (MUAC) Secondary · 12 weeks

Mid-upper arm circumference (centimeters) will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit).

Group	Value	95% CI
Amoxicillin	12.70	± 0.70
Azithromycin	12.73	± 0.52

Weight-for-age Z-score (WAZ) Secondary · 12 weeks

Weight will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit) and weight-for-age z-scores will be calculated. 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 WAZ \< -2 standard distributions below the median is defined as underweight, while a WAZ \< -3 standard distributions below

Group	Value	95% CI
Amoxicillin	-2.67	± 1.31
Azithromycin	-2.48	± 0.95

Adverse events — posted to ClinicalTrials.gov

Time frame: Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Amoxicillin

Serious: 1/133 (1%)

Deaths: 4/42

Azithromycin

Serious: 0/142 (0%)

Deaths: 3/58

Serious adverse events (1 terms)

Reaction	System	Amoxicillin	Azithromycin
Death in 7 days	General disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Amoxicillin	Azithromycin
weight loss	General disorders	—	—
severe fever	General disorders	—	—
vomiting	Gastrointestinal disorders	—	—

Most-reported serious reactions: Death in 7 days.

Data from ClinicalTrials.gov NCT05473234 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.