# Global Network for Women's and Children's Health Research Data Coordinating Center

> **NIH NIH U24** · RESEARCH TRIANGLE INSTITUTE · 2021 · $500,000

## Abstract

Supplement for the Global Network for Women’s and Children’s Health Research’s A-PLUS 
Antimicrobial Resistance Study  
Project Summary 
The Global Network is currently undertaking a trial of azithromycin to reduce risk of sepsis and 
newborns (A-PLUS). An important question to understand is the prevalence of antimicrobial resistance 
among women exposed to azithromycin. Thus, this supplement will be used to support the ongoing 
serial collection of clinical specimens from mothers and infants, and testing of these specimens for 
Azithromycin-resistant bacteria by culture to 3 months for all dyads (regardless of resistance at 6 weeks) 
and a final sample collection between 6 and 12 months post-partum for culture of maternal and infant 
samples (Nasopharyngeal [NP]and rectal) to also test for Azithromycin-resistant bacteria by culture. 
Samples from all timepoints will be used to assess the maternal and infant microbiome and to assess the 
effects of the single dose of prophylactic azithromycin on the resistome by identifying and determining 
the duration of any potential dysbiosis and presence of resistance genes in the microbial communities.  
Specifically, supplemental funds to the data coordinating center will support the activities of the sub-study outlined below:  
* Facilitating sample collection, testing for anti-microbial resistance for 3 month duration followed 
by final sample collection at 6 and 12 months post-partum in sub-set of mother -infant dyads  
* Procuring and shipping supplies for NP swabs and rectal swabs to the 8 Global Network Sites. 
* Providing labels, tracking and analyses of participant’s enrolled in the sub-study. 
* Managing the shipments of samples from the 8 sites to UAB for analyses, including:   
o shipping NP swabs and rectal swab specimens in stabilizing buffer on dry ice from the 8 
Global Network Sites to the University of Alabama at Birmingham. 
o shipping  bacterial isolates from routine clinical cultures on dry ice from the 8 Global 
Network Sites to University of Alabama at Birmingham. 
* Statistical data analyses of the associations with outcomes to the microbiome and resistome 
analyses.   
* maintaining the database with the participant characteristics and outcomes and make these 
data available for public use, as indicated. 
In summary, the proposed work will address the global concerns about use of azithromycin in laboring 
women with a comprehensive evaluation of the risk of azithromycin resistance and the changes in 
maternal-neonatal microbiome and resistome over time and across the diverse populations enrolled in 
the Global Network Trial. Without the supplemental funds and the above new studies, we will not be 
able to optimally determine the extent and duration of risk of antimicrobial resistance patterns in this 
large multi-country study of women and children who were exposed to azithromycin which may be 
beneficial in preventing infection/mortality and also be neuroprotective for the children...

## Key facts

- **NIH application ID:** 10474098
- **Project number:** 3U24HD092094-05S1
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** Elizabeth M McClure
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $500,000
- **Award type:** 3
- **Project period:** 2021-09-09 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10474098

## Citation

> US National Institutes of Health, RePORTER application 10474098, Global Network for Women's and Children's Health Research Data Coordinating Center (3U24HD092094-05S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10474098. Licensed CC0.

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