Viewing Study NCT06257147



Ignite Creation Date: 2024-05-06 @ 8:07 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06257147
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-20
First Post: 2024-02-06

Brief Title: Antimicrobial Stewardship for Enterobacterales Bacteremia Management
Sponsor: Chinese University of Hong Kong
Organization: Chinese University of Hong Kong

Study Overview

Official Title: A Cluster-randomized Controlled Pragmatic Trial to Evaluate Antimicrobial Stewardship Strategies for Short-course and Oral-switch Antibiotic Therapy for Bloodstream Infections Due to Enterobacterales
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: We hypothesize that a multifaceted antibiotic stewardship intervention incorporating physician education prospective chart review with antibiotic recommendation and provision of follow-up by a multidisciplinary antibiotic stewardship team is more effective than physician education and reminders alone in improving physicians prescription of short-course and oral-switch antibiotic therapy for patients with bloodstream infections due to Enterobacterales BSI-E

This study is to

1 determine the effectiveness of a multifaceted antibiotic stewardship intervention in improving physicians prescription of short-course antibiotic therapy for BSI-E
2 determine the effectiveness of a multifaceted antibiotic stewardship intervention in improving physicians de-escalation to oral antibiotic therapy for BSI-E
Detailed Description: Antimicrobial resistance is a major global threat causing 5 million deaths globally in 2019 One of the crucial strategies to control the emergence and spread of multidrug-resistant organisms MDRO is to minimize unnecessary antibiotics exposure

Shorter duration of antibiotic therapy and oral-switch therapy for bloodstream infection due to Enterobacterales BSI-E had demonstrated similar treatment success and clinical outcomes as compared with longer courses in randomized controlled trials Despite the release of such data clinicians may be reluctant to shortern duration of therapy for BSI-E and adopt oral-switch approach

This study aims to determine the optimal approach to aid clinicians in adopting evidence-based practice in a clinical setting This study is a pragmatic cluster-randomized controlled trial in the medical wards of an acute hospital A cluster as the unit of randomization is a medical ward Medical wards will be randomized to three groups 1 physician education only 2 physician education and paper reminder 3 multifaceted antibiotic stewardship intervention The prescription of antibiotic therapy by treating physicians and outcomes of patients with BSI-E will be studied

Patients antibiotics regimen and clinical outcomes in the three groups will be compared

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None