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

• Status: Completed
• Trial end date: 2020-12-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Centre de Recherche en Sante de Nouna, Burkina Faso; Centre de Recherche et Interventions en Sante Publique (CRISP); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Francis I. Proctor Foundation, University of California, San Francisco
• Treatments: Amoxicillin; Azithromycin

Criteria

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