Clinical trial NCT05734391: Surveillance of Healthcare-associated Infections & Antimicrobial Resistance
Official title: Surveillance of Healthcare-associated Infections & Antimicrobial Resistance
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Antimicrobial Resistance
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

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

Primary outcomes:
measure: Expertise
timeFrame: 12 months
Secondary outcomes:
measure: Feasibility and Surveillance
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Gaborone
country: Botswana
facility: Princess Marina Hospital
Study officials:
affiliation: University of Pennsylvania
name: Ebbing Lautenbach, MD, MPH, MSCE
role: PRINCIPAL_INVESTIGATOR
References: