NCT03382470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,115

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

12 months

First QC Date

December 19, 2017

Last Update Submit

July 15, 2019

Conditions

Resistance Bacterial

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Antimicrobial stewardship adviceOTHER

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Teaching Hospital Karapitiya

Galle, Sri Lanka

Location

Study Officials

  • Gayani Tillekeratne, MD MSc

    Assistant Professor of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

March 12, 2018

Primary Completion

March 8, 2019

Study Completion

March 8, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

SR(1)