NCT06617260

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Feb 2024Feb 2027

Study Start

First participant enrolled

February 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

September 25, 2024

Last Update Submit

November 14, 2025

Conditions

Keywords

Antimicrobial

Outcome Measures

Primary Outcomes (1)

  • Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition

    Ultimately, the goal of the LWAPA study is to better understand perinatal transmission of AMR in order to inform prevention measures

    12 months

Study Arms (1)

Neonates and mothers

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) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU

Eligibility Criteria

Age36 Weeks+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPre partum mothers
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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) The rationale for recruiting these mothers is that there is a high probability of having a baby who will ultimately be admitted to the NNU

You may qualify if:

  • 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)-

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Marina Hospital

Gaborone, 267, Botswana

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Rectovaginal swabs

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

February 15, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations