# Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition: the AMOUR trial

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2024 · $622,142

## Abstract

PROJECT SUMMARY/ABSTRACT
Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment
of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have
asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic
may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo-
controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting
results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated
SAM, or that a better antibiotic is needed. Recently, we demonstrated that biannual mass azithromycin
distribution as a single oral dose reduces all-cause child mortality in sub-Saharan Africa. Children with
uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may
particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid
enrollment of children with uncomplicated SAM in our study area, and showed no significant difference
between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, we propose an
individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c)
placebo, and evaluated for differences in weight gain, nutritional recovery, and the gut microbiome. The results
of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the
management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as
evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to
changes in guidelines for treatment.

## Key facts

- **NIH application ID:** 10797579
- **Project number:** 1R01HD111532-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Catherine Elizabeth Oldenburg
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $622,142
- **Award type:** 1
- **Project period:** 2023-12-08 → 2028-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10797579

## Citation

> US National Institutes of Health, RePORTER application 10797579, Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition: the AMOUR trial (1R01HD111532-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10797579. Licensed CC0.

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