Antimicrobial Stewardship for Enterobacterales Bacteremia Management

Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06257147
• Other study ID #: ASP BSI Protocol
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: March 2024
• Source: Chinese University of Hong Kong
• Contact: Catherine Cheung
• Phone: 35053376
• Email: catherinecheung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged =18 years;

• hospitalization in one of the medical wards of the hospital; and

• isolation of Enterobacterales in at least one blood culture bottle, where Enterobacterales include Escherichia coli, Klebsiella, Proteus, Enterobacter, Serratia, Citrobacter, Providencia and Morganella species.

Exclusion Criteria:

• concomitant isolation of pathogens other than Enterobacterales in blood or other relevant clinical specimens;

• infections requiring prolonged courses of antibiotics, such as intra-abdominal abscess, central nervous system infection, endocarditis, lung abscess or empyema, osteomyelitis, and prostatitis;

• focus of infection not controlled;

• nosocomial infection with onset within 7 days; or

• Presence of neutropenia, allogenic stem cell transplant within one year, use of high-dose steroid (>40mg prednisolone or equivalent for > 2 weeks), or

• died before day 7 will be excluded from the analysis, or

• already on more than 7 days of antibiotics for BSI-E at the time of screening.

Related Conditions & MeSH terms

• Infections

Intervention

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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients receiving 7 days effective antibiotic therapy for the treatment of BSI-E	proportion of patients receiving 7 days of effective antibiotic therapy for the treatment of BSI-E	7 days
Secondary	proportion of patients with susceptible oral antibiotics completed the course with an oral antibiotic	proportion of patients with susceptible oral antibiotics completed the course with an oral antibiotic	during hopsitalization
Secondary	30-day all-cause mortality	30-day all-cause mortality	30 day since hospital admission
Secondary	clinical failure	clinical failure , defined as relapse of BSI-E due to the same Enterobacterales, local suppurative complications or distant complications due to the same pathogen within 90 days	within 90 days since hopsitalization
Secondary	length of stay in hospital	length of stay in hospital	from the admission up to the discharge
Secondary	re-admission to hospital within 90 days	re-admission to hospital within 90 days	within 90 days since discharge