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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05734391
Other study ID # 851492
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date December 20, 2023

Study information

Verified date March 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Completed
Enrollment 1500
Est. completion date December 20, 2023
Est. primary completion date December 20, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Routine Infection control
routine part of hospital IPC activities

Locations

Country Name City State
Botswana Princess Marina Hospital Gaborone
United States University of Pennsylvania School of Medicine Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Countries where clinical trial is conducted

United States,  Botswana, 

Outcome

Type Measure Description Time frame Safety issue
Primary Expertise 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 Feasibility and Surveillance 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
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