Azithromycin to help recovery in children with severe acute malnutrition
Official title: Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition: the AMOUR trial
Funded at University of California, San Francisco · NIH-11229612 · Data updated 2026-11-12
This project compares a single dose of azithromycin, a course of amoxicillin, or a placebo to see which helps young children with uncomplicated severe acute malnutrition gain weight and recover better.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of California, San Francisco NIH-funded |
| Lab location | 1 site (San Francisco, United States) |
| Project start | December 8, 2023 |
| Project end | November 30, 2028 |
| Funding year | 2026 |
| Award (this year) | $469,343 |
| NIH project number | 5R01HD111532-03 |
| Project ID | NIH-11229612 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates are children diagnosed with uncomplicated severe acute malnutrition who are receiving outpatient therapeutic care at participating sites in the study area.
✕Less likely to help
Children with complicated SAM who need inpatient or emergency care, children without SAM, or those living outside the study locations would not be eligible and would not directly benefit from participation.
What this research studies
If your child joins, they would be randomly assigned to receive a single dose of azithromycin, a course of amoxicillin, or a placebo alongside standard outpatient nutrition care. Clinicians will measure weight gain, track whether the child reaches nutritional recovery, and collect stool samples to study the gut microbiome during follow-up. The trial targets children treated for uncomplicated severe acute malnutrition at outpatient sites in sub-Saharan Africa. The team designed this larger trial after a pilot showed rapid enrollment was possible and to follow up on mixed prior results with amoxicillin and promising findings from mass azithromycin programs.
Why it matters
Potential benefit: If successful, the trial could identify a simpler and more effective antibiotic approach that improves weight gain, recovery, and survival for children with uncomplicated severe acute malnutrition.
How similar studies have gone: Previous randomized trials of amoxicillin in uncomplicated SAM had conflicting results, while community-wide azithromycin distributions reduced child mortality in other studies and a pilot comparing azithromycin and amoxicillin showed equipoise, so this larger trial builds on mixed but promising evidence.
Where this research is happening
-
University of California, San Francisco
San Francisco, United States Active
Researchers
- Principal investigator: Oldenburg, Catherine Elizabeth — University of California, San Francisco
- Study coordinator: Oldenburg, Catherine Elizabeth
Related research
Other NIH-funded projects on the same topics.
-
Azithromycin added to standard care for kids with severe malnutrition in Africa
This project tests whether giving azithromycin as an extra antibiotic to young children with uncomplicated severe acute malnutrition improves weight gain and recovery compared with amoxicillin or placebo.
-
Gut-Liver-Bone clues to growth problems in malnourished children
A study in malnourished children and a mouse model looks at how the gut, liver, and bone interact to cause growth faltering and tests a bile-acid therapy that could improve growth and reduce inflammation.
-
Azithromycin adjunct in kids with severe malnutrition in Africa
A randomized trial will compare azithromycin, amoxicillin, and placebo as adjunctive antibiotics for children with uncomplicated severe acute malnutrition to see which supports better weight gain and recovery.
-
Digital tools to fight adolescent malnutrition in schools (low-resource settings)
A school-based mobile health approach helps younger adolescents in low-resource areas improve nutrition and health behaviors.
-
How caregiver mental health affects recovery from severe malnutrition in young children
This project will track caregivers' depression and anxiety while their children get treatment for severe acute malnutrition to learn how caregiver mental health relates to child recovery and relapse.
-
Preventing Growth Problems in Poor Children by Treating Small Intestine Bacteria
A phase II effort in urban Bangladesh tests a treatment plan to stop growth failure and malnutrition in young children by addressing small intestinal bacterial overgrowth.
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.