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

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ClinicalTrials.gov Identifier: NCT03382470
Recruitment Status : Completed
First Posted : December 26, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Moi University
Kilimanjaro Christian Medical Centre, Tanzania
Ruhuna University, Sri Lanka
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment
Resistance Bacterial Other: Antimicrobial stewardship advice

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.

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Study Type : Observational
Actual Enrollment : 3115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Partnership to Enhance Antimicrobial Use in Resource-Limited Settings (PEARL): An Assessment of Need and Feasibility of Antimicrobial Stewardship Programs
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics


Intervention Details:
  • Other: Antimicrobial stewardship advice
    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 Outcome Measures :
  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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria: All patients admitted to the medical wards -

Exclusion Criteria: None

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382470


Locations
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Sri Lanka
Teaching Hospital Karapitiya
Galle, Sri Lanka
Sponsors and Collaborators
Duke University
Moi University
Kilimanjaro Christian Medical Centre, Tanzania
Ruhuna University, Sri Lanka
Investigators
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Principal Investigator: Gayani Tillekeratne, MD MSc Assistant Professor of Medicine

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03382470     History of Changes
Other Study ID Numbers: Pro00089077
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Infective Agents
Anti-Bacterial Agents