Impact of Antimicrobial Stewardship Programs in the Global Setting (PEARL)

July 15, 2019 updated by: Duke University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

3115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
      • Galle, Sri Lanka
        • Teaching hospital Karapitiya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the adult medical wards at the three hospitals during the duration of the study will be eligible.

Description

Inclusion Criteria: All patients admitted to the medical wards -

Exclusion Criteria: None

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

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

Investigators

  • Principal Investigator: Gayani Tillekeratne, MD MSc, Assistant Professor of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2018

Primary Completion (Actual)

March 8, 2019

Study Completion (Actual)

March 8, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00089077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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