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Completed

NCT Number: NCT03382470

Impact of Antimicrobial Stewardship Programs in the Global Setting

Antimicrobial resistance is one of the greatest threats to human health, and is driven by inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials in hospitals. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Teaching Hospital Karapitiya

Galle, Sri Lanka

About this study

Antimicrobial resistance is one of the greatest threats to human health, and is driven by the inappropriate antimicrobial use. Antimicrobial stewardship programs (ASPs) improve the use of antimicrobials. The purpose of this study is to identify the need for and barriers to implementation of ASPs in three hospitals in Sri Lanka, Kenya, and Tanzania. The impact of creating a basic ASP will be assessed at each hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients admitted to the medical wards -

Exclusion criteria

None

-

Treatment and study plan

Antimicrobial stewardship advice

Other

A basic antimicrobial stewardship team will be created at each site. The team will provide advice on the treatment of urinary tract infections and asymptomatic bacteriuria during the second half of the study.

Primary outcomes

  1. Appropriate antimicrobial use, for example for urinary syndromes

    Time frame: 6 months

    A composite outcome will be created for 'inappropriate' antibiotic use. This outcome will consist of 1) Unnecessary treatment for asymptomatic bacteriuria, 2) Inappropriate duration of therapy for urinary tract infection (UTI)/ cystitis/ pyelonephritis (binary outcome- yes/no), and 3) Unnecessary double coverage for UTI/ cystitis/ pyelonephritis (binary outcome- yes/no)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania
  • Moi University
  • Ruhuna University, Sri Lanka

Registry information

Official study title

Partnership to Enhance Antimicrobial Use in Resource-Limited Settings (PEARL): An Assessment of Need and Feasibility of Antimicrobial Stewardship Programs

Acronym: PEARL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2017
Registry last updated
Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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