Impact of Antimicrobial Stewardship Programs in the Global Setting

Resistance Bacterial Clinical Trial

— PEARL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382470
• Other study ID #: Pro00089077
• Status: Completed
• Start date: March 12, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: July 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3115
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria: All patients admitted to the medical wards -

Exclusion Criteria: None

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Related Conditions & MeSH terms

• Resistance Bacterial

Intervention

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.

Locations

Country	Name	City	State
Sri Lanka	Teaching Hospital Karapitiya	Galle

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Kilimanjaro Christian Medical Centre, Tanzania, Moi University, Ruhuna University, Sri Lanka

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appropriate antimicrobial use, for example for urinary syndromes	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