PEARL: Impact of Antimicrobial Stewardship Programs in the Global Setting

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03382470
• Collaborator: Moi University (Other), Kilimanjaro Christian Medical Centre, Tanzania (Other), Ruhuna University, Sri Lanka (Other)
• Enrollment: 3,115
• Location: 1
• Actual Duration (Months): 11.9
• Patients Per Site Per Month: 262.6

Study Details

Study Description

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	Phase
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.

Study Design

• 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: Mar 12, 2018
• Actual Primary Completion Date: Mar 8, 2019
• Actual Study Completion Date: Mar 8, 2019

Outcome Measures

Primary Outcome Measures

1. Appropriate antimicrobial use, for example for urinary syndromes [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: All patients admitted to the medical wards -

Exclusion Criteria: None

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teaching Hospital Karapitiya	Galle		Sri Lanka

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03382470
• Other Study ID Numbers: Pro00089077
• First Posted: Dec 26, 2017
• Last Update Posted: Jul 17, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents

Study Results

No Results Posted as of Jul 17, 2019