Surveillance of Healthcare-associated Infections & Antimicrobial Resistance

Antimicrobial Resistance Clinical Trial

Official title:

Surveillance of Healthcare-associated Infections & Antimicrobial Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05734391
• Other study ID #: 851492
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Antimicrobial Resistance
• Cross Infection

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