- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05734391
Surveillance of Healthcare-associated Infections & Antimicrobial Resistance
September 11, 2025 updated by: Ebbing Lautenbach, University of Pennsylvania
The aims of this project, called "Surveillance of Healthcare-associated infections & Antimicrobial Resistance", or "SHARE", are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs to use 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 infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
The World Health Organization (WHO) has declared antimicrobial resistance (AMR) one of the top 10 global public health threats facing humanity.
AMR burden is higher in low-and-middle-income countries (LMICs) where, in recent decades, incidence and mortality from healthcare-associated infections (HAI) due to multidrug resistant organisms (MDRO) have dramatically increased.
For example, neonatal sepsis is the third most common cause of neonatal deaths and multidrug-resistant Gram-negative bacteria are now the leading cause of sepsis among hospitalized neonates in south Asia and sub-Saharan Africa, including Botswana.1,2
One in three newborns with an MDRO bloodstream infection will die.3
In 2021, to respond to the global threat of AMR, U.S. Centers for Disease Control & Prevention (CDC) announced the launch of a global "network of networks" to tackle the problem of AMR and healthcare-associated infections (HAIs).
The network, called "Global Antimicrobial Resistance Laboratory and Response Network", solicited funding applications; in December of 2021, Botswana was announced as recipient of a 5-year cooperative agreement following the successful application for funding for a comprehensive AMR surveillance project.
The project was developed by investigators from Botswana-UPenn Partnership (BUP) in collaboration with Botswana's Ministry of Health & Wellness (MOHW) and the University of Botswana (UB).
Study Type
Observational
Enrollment (Estimated)
1500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gaborone, Botswana, 267
- Princess Marina Hospital
-
-
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania School of medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
individuals being admitted to participating wards, of all clinical conditions, genders, and ages, meeting the inclusion/exclusion criteria
Description
Inclusion Criteria:
- hospital inpatient admission to participating wards.
Exclusion Criteria:
- diagnosis of a bleeding disorder
- platelet counts of <50,000
- diagnosis of coagulopathy
- presence of active bleeding
- inability to have a nares swab collected due to some other condition where nasal swabbing would be contraindicated
- inability to have a rectal swab collected due to some other condition where rectal swabbing would be contraindicated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
inpatients
Individuals in inpatient wards
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routine part of hospital IPC activities
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expertise
Time Frame: 12 months
|
Ultimately, the goal of the SHARE project is to assemble the expertise and infrastructure needed to build a resilient HAI/AMR surveillance system fully-incorporated into MOHW's surveillance activities.
The project aims to build capacity, both material and knowledge, in existing laboratory and IPC teams to face the dynamic challenges posed by HAIs and AMR
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility and Surveillance
Time Frame: 12 months
|
SHARE's "Colonization Feasibility Study", will seek to assess the feasibility and surveillance potential of routine MDRO screening in hospitals, determining whether MDRO colonization can provide an "early warning system" for emerging AMR threats
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ebbing Lautenbach, MD, MPH, MSCE, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Estimated)
December 20, 2027
Study Completion (Estimated)
December 20, 2027
Study Registration Dates
First Submitted
February 8, 2023
First Submitted That Met QC Criteria
February 8, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Estimated)
September 12, 2025
Last Update Submitted That Met QC Criteria
September 11, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 851492
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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