Effect of Commonly Used Pediatric Antibiotics on Gut Microbial Diversity in Preschool Children in Burkina Faso: A Randomized Clinical Trial.
Catherine E Oldenburg, Ali Sié, Boubacar Coulibaly...
https://pubmed.ncbi.nlm.nih.gov/30515431Actively Recruiting
Phase 4
Age: 6Months - 59Months
All Genders
ID06010719
Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition: the AMOUR Trial
Led by University of California, San Francisco · Updated on 2025-10-15
3000
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
C
Centre de Recherche en Sante de Nouna, Burkina Faso
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of antibiotics as part of treatment for children aged 6 to 59 months with uncomplicated severe acute malnutrition (SAM). This trial compares azithromycin, amoxicillin, and placebo to determine their effects on weight gain, nutritional recovery, and gut health. The study addresses uncertainty about whether antibiotics help manage uncomplicated SAM and aims to provide evidence that may influence treatment guidelines, focusing on a vulnerable region in Burkina Faso where malnutrition is highly seasonal and a significant health concern. Children will be randomly assigned to one of three groups: a single oral dose of azithromycin followed by placebo for 7 days, a 7-day twice-daily course of amoxicillin, or a 7-day twice-daily course of placebo. All children will receive ready-to-use therapeutic food according to standard care. The trial will take place over three malnutrition seasons at multiple health facilities, with a total follow-up period of 12 months. Participants will be assessed weekly until nutritional recovery and then at 8 weeks, 3, 6, 9, and 12 months to monitor weight gain, relapse, mortality, and other health outcomes. Researchers will collect data on weight gain as the primary outcome at 8 weeks, along with secondary outcomes like time to recovery, need for inpatient care, and mortality over 12 months. The study includes close monitoring and support, ensuring children receive full outpatient care throughout the trial.
CONDITIONS
Brief Title
Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
Who Can Participate
Age: 6Months - 59Months
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 6 to 59 months
- Severe acute malnutrition defined by weight-for-height Z-score less than -3 SD or mid-upper arm circumference less than 115 mm
- Primary residence within catchment area of an enrollment site
- Available for the full 8-week primary endpoint study period
- No admission to a nutritional program for SAM treatment in the previous 2 weeks
- No edema present
- No antibiotic use in the past 7 days
- No clinical complications requiring antibiotics or inpatient treatment
- No congenital abnormalities or chronic illnesses likely to cause growth faltering or reduce treatment benefit
- No known allergies to macrolides, azalides, amoxicillin, or penicillin
- Sufficient appetite as determined by a feeding test with ready-to-use therapeutic food
- Written informed consent from at least one parent or guardian
You will not qualify if you...
- Age less than 6 months or more than 59 months
- Weight-for-height Z-score greater than -3 SD or mid-upper arm circumference greater than 115 mm
- Primary residence outside catchment area of an enrollment site
- Not available for the full 8-week study period
- Admission to a nutritional program for SAM treatment in the previous 2 weeks
- Presence of edema
- Antibiotic use in the past 7 days
- Clinical complications requiring antibiotic or inpatient treatment
- Congenital abnormalities or chronic illnesses that would lead to predictable growth faltering or reduce treatment benefit
- Known allergies to macrolides, azalides, amoxicillin, or penicillin
- Insufficient appetite according to feeding test with ready-to-use therapeutic food
- No written informed consent from a parent or guardian
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 7 days
Participants receive a randomized treatment: either a single dose of azithromycin followed by placebo, a 7-day twice-daily course of amoxicillin, or a 7-day twice-daily course of placebo. All participants receive standard outpatient severe acute malnutrition treatment including ready-to-use therapeutic food.
Daily visits for medication administration and monitoring during the 7-day treatment period
Follow-up
Duration - Up to 12 months
Participants are followed weekly until nutritional recovery, then at 8 weeks, and every 3 months up to 12 months to monitor nutritional status, relapse, and survival.
Weekly visits until recovery, then visits at 8 weeks, and at 3, 6, 9, and 12 months
Trial Site Locations
Total: 1 location
1
Centre de recherche en Santé de nouna
Nouna, Kossi, Burkina Faso
Actively Recruiting
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Research Team
C
Catherine Oldenburg, ScD
E
Elodie Lebas, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial.
Mamadou Bountogo, Alphonse Zakane, Thierry A Ouedraogo...
https://pubmed.ncbi.nlm.nih.gov/40592757