Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period

• Conditions: Drug Resistance, Microbial

• Registration Number: NCT06617260
• Lead Sponsor: University of Pennsylvania

Brief Summary

In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \& Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections \& Antimicrobial Resistance", or "SHARE". The aims of SHARE are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs, leveraging data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of hospital infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats.

Detailed Description

The Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (LWAPA) study will assess the extent of perinatally-acquired MDROs and GBS, exploring factors influencing both maternal and neonatal colonization and better understanding the long-term outcomes in families affected by MDRO colonization.

By collecting samples at critical time points (e.g. during labour, after delivery, sequentially in the hospital, and then 3, 6, 9, and 12 months of age, the LWAPA study aims to identify modifiable factors influencing colonization risk. The results from this study can help inform and operationalize infection prevention measures which are poised to reduce the incidence of healthcare-associated infections and other poor health outcomes.

In Setswana, 'lwapa' means 'home' or 'family', which captures how this study aims to understand healthcare-associated AMR is impacting households and communities.

Study Timeline

• Study Start: 2024-02-15
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:

• Pre-term labor (24-36 weeks gestation)
• Pre-eclampsia
• Post-dates (>41 weeks gestation)-

Exclusion Criteria

Mothers/babies who have been admitted for more than 96 hours will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antimicrobial resistance	12 months	Ultimately, the goal of the LWAPA study is to better understand perinatal transmission of AMR in order to inform prevention measures

Trial Locations

Locations (1)

Princess Marina Hospital; 🇧🇼 Gaborone, Botswana