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Clinical Trials/NCT05734391
NCT05734391
Enrolling By Invitation
Not Applicable

Surveillance of Healthcare-associated Infections & Antimicrobial Resistance

University of Pennsylvania2 sites in 2 countries1,500 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antimicrobial Resistance
Sponsor
University of Pennsylvania
Enrollment
1500
Locations
2
Primary Endpoint
Expertise
Status
Enrolling By Invitation
Last Updated
7 months ago

Overview

Brief 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

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).

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
December 20, 2027
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ebbing Lautenbach

Corrado Cancedda

University of Pennsylvania

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Feasibility and Surveillance(12 months)

Study Sites (2)

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