Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

NCT05473234 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 22-36912
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Weight Gain at 8 Weeks

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

  8 weeks

Secondary Outcomes (1)

• Number of Participants With Nutritional Recovery at 8 Weeks

  8 weeks

Other Outcomes (12)

• Weight Gain Over 12 Weeks

  12 weeks

• Time to Recovery

  12 weeks

• Nonresponse at 8 Weeks

  8 weeks

Study Arms (2)

Azithromycin

EXPERIMENTAL

Children in this arm will receive one dose of amoxicillin.

Drug: Azithromycin

Amoxicillin

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Interventions

Azithromycin 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.

Azithromycin

Amoxicillin 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.

Amoxicillin

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• The Taimaka Project: collaborator

Study Sites (1)

The Tamaika Project

Gombe, Gombe State, 760252, Nigeria

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Interventions

Azithromycin; Amoxicillin

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Catherine E. Oldenburg
• Organization: UCSF FI Proctor

catherine.oldenburg@ucsf.edu

415-502-8843

Study Officials

• Kieran S O'Brien, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 25, 2022
• Study Start: October 6, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: February 25, 2025
• Results First Posted: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)