# The role of enteric pathogens and antimicrobial resistance in driving clinical and nutritional deterioration, and azithromycin's potential effect, among children discharged from hospital in Kenya

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2024 · $703,337

## Abstract

PROJECT SUMMARY/ABSTRACT
More than 2 million children under 5 die each year in sub-Saharan Africa (SSA). Children recently discharged
from hospital suffer a particularly high risk of death and no interventions target this period. Recent clinical trials
found 13%-49% mortality reductions associated with community-wide singe-dose azithromycin in SSA, and
mechanisms of this effect are poorly understood. The Toto Bora trial (NIH/NICHD-HD079695) is a double-blind
placebo-controlled randomized clinical trial (RCT) testing the effect of a 5-day course of azithromycin
administered at hospital discharge to Kenyan children under 5 years on mortality and re-hospitalization in the
subsequent 6-months. Utilizing samples from this trial, we have the unprecedented opportunity to elucidate
mechanisms of post-discharge morbidity, mortality, and growth faltering AND determine mechanisms of
azithromycin’s effect. We will test for enteropathogens and resistance genes in fecal samples and Escherichia
coli collected from children at hospital discharge and 3-months thereafter using qPCR and link this molecular
data to re-hospitalization, vital status, and anthropometric data collected throughout the 6-month post-discharge
period. Results from this highly efficient nested study will inform targets for vaccines and pathogen-directed
medications that could reduce post-discharge morbidity and mortality. Specific molecularly-determined pathogen
or resistance markers that predict azithromycin’s effects on mortality, morbidity, and growth will elucidate
mechanisms by which empiric azithromycin reduces child mortality and may identify specific populations who
can be treated with azithromycin to maximize benefit while minimizing resistance.

## Key facts

- **NIH application ID:** 10809682
- **Project number:** 5R01AI150978-05
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Patricia Pavlinac
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $703,337
- **Award type:** 5
- **Project period:** 2020-03-15 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10809682

## Citation

> US National Institutes of Health, RePORTER application 10809682, The role of enteric pathogens and antimicrobial resistance in driving clinical and nutritional deterioration, and azithromycin's potential effect, among children discharged from hospital in Kenya (5R01AI150978-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10809682. Licensed CC0.

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