Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot) (SAM)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 3

Conditions

Uncomplicated Severe Acute Malnutrition

Treatments

Drug: Azithromycin

Drug: Amoxicillin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03568643

18-25274

1R21HD100932-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.

Enrollment

301 patients

Sex

All

Ages

6 to 59 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 6-59 months
WHZ <-3 SD or MUAC <115 mm
No nutritional edema
Able and willing to participate in full 8-week study
Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
No antibiotic use in past 7 days
No clinical complications requiring inpatient treatment (except for routine admission for children <6 months)
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, etc)
No allergy to macrolides/azalides
Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
Appropriate consent from at least one parent or guardian

Exclusion criteria

Age <6 months or >59 months
WHZ ≥-3 SD or MUAC ≥115 mm
Nutritional edema
Not able or willing to participate in full 8-week study
Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
Antibiotic use in past 7 days
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