# Azithromycin in the Outpatient Management of Severe Acute Malnutrition

> **NIH NIH R21** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $185,150

## 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 are more likely
to have asymptomatic infection, 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. Here, we propose a pilot and feasibility study to evaluate the potential for development
of a full-scale randomized controlled trial to test a single dose of azithromycin as compared to amoxicillin and
placebo. We anticipate that the results will provide valuable pilot data and allow for refinement of study
procedures, allowing for development of a full-scale randomized controlled trial to provide evidence for the role
of azithromycin in the management of uncomplicated SAM.

## Key facts

- **NIH application ID:** 10056186
- **Project number:** 1R21HD100932-01A1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Catherine Elizabeth Oldenburg
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $185,150
- **Award type:** 1
- **Project period:** 2020-09-06 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10056186

## Citation

> US National Institutes of Health, RePORTER application 10056186, Azithromycin in the Outpatient Management of Severe Acute Malnutrition (1R21HD100932-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10056186. Licensed CC0.

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