Azithromycin for Severe Acute Malnutrition in CMAM, Nigeria

University of California San Francisco (UCSF)

Status and phase

Terminated

Phase 3

Conditions

Severe Acute Malnutrition

Treatments

Drug: Amoxicillin

Drug: Azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT05473234

22-36912

Details and patient eligibility

About

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.

Enrollment

310 patients

Sex

All

Ages

6 to 59 months old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria (all must be met):

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 (any excludes):

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