NCT06257147

Antimicrobial Stewardship for Enterobacterales Bacteremia Management

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infections

Interventions

Type	Name	Description
BEHAVIORAL	multifaceted antibiotic stewardship intervention	Group 3 wards will receive a multifaceted antibiotic stewardship intervention. Physician education will be provided as in Group 1. All consecutive patients fulfilling inclusion and exclusion criteria for study eligibility will be assessed by an Antibiotic Stewardship team. A trained nurse will first assess the patients for clinical and host criteria to determine eligibility for short-course antibiotic therapy. The antibiotic susceptibility test results and the prescribed antibiotics treatment will be reviewed. An Infectious Diseases physician will subsequently make written recommendations for the duration and choice of antibiotic therapy, and provide an appointment within 2 weeks after hospital discharge to review patients' clinical condition when indicated.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2024-02-13
• Last updated: 2024-03-20

Locations

1 site across 1 country: Hong Kong