Phase 3
N=301
Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Uncomplicated Severe Acute Malnutrition
Bottom Line
View on ClinicalTrials.gov: NCT03568643 ↗Enrolled (actual)
301
Serious AEs
27.9%
Results posted
Sep 2022
Primary outcome: Primary: Weight Gain — 1.8; 2.0 g/kg/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azithromycin (Drug); Amoxicillin (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Gain |
1.8; 2.0 | — |
| SECONDARY Nutritional Recovery - Primary Definition |
56; 48 | — |
| SECONDARY Nutritional Recovery - Secondary Definition |
98; 87 | — |
| SECONDARY Malaria |
13; 15 | — |
| SECONDARY Mortality |
2; 1 | — |
| SECONDARY Length/Height-for-age Z-score (LAZ/HAZ) |
-2.3; -2.37 | — |
| SECONDARY Mid-Upper Arm Circumference (MUAC) |
12.4; 12.3 | — |
| SECONDARY Weight-for-Age Z-scores (WAZ) |
-2.58; -2.65 | — |
| SECONDARY Weight-for-Height Z-score (WHZ) |
-1.89; -1.95 | — |
| SECONDARY Intestinal Microbiome |
4.0; 5.1; 6.6; 8.3; 4.5; 5.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 6-59 months
- WHZ 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
Data sourced from ClinicalTrials.gov (NCT03568643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.