Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

NCT ID: NCT05473234

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2023-11-29

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.

Conditions

Severe Acute Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Azithromycin

Children in this arm will receive one dose of amoxicillin.

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

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.

Amoxicillin

Children in this arm will receive a 5-day course of amoxicillin (standard care).

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Taimaka Project

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kieran S O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

The Tamaika Project

Gombe, Gombe State, Nigeria

Countries

Nigeria

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22-36912

Identifier Type: -

Identifier Source: org_study_id