Antimicrobial Stewardship for Enterobacterales Bacteremia Management

NCT06257147 | Not Yet Recruiting

• 1 other identifier: ASP BSI Protocol
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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. 1.determine the effectiveness of a multifaceted antibiotic stewardship intervention in improving physicians' prescription of short-course antibiotic therapy for BSI-E
2. 2.determine the effectiveness of a multifaceted antibiotic stewardship intervention in improving physicians' de-escalation to oral antibiotic therapy for BSI-E

Conditions

Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• proportion of patients with susceptible oral antibiotics completed the course with an oral antibiotic

  during hopsitalization

• 30-day all-cause mortality

  30 day since hospital admission

• clinical failure

  within 90 days since hopsitalization

• length of stay in hospital

  from the admission up to the discharge

• re-admission to hospital within 90 days

  within 90 days since discharge

Study Arms (3)

Group 1 wards (physician education)

PLACEBO COMPARATOR

For Group 1 wards, physician education will be provided. All physicians treating patients in general medical wards will undergo a training session at the start of the study. Education content includes latest evidence on short-course antibiotic therapy and criteria for de-escalation to oral antibiotics for BSI-E. The educational materials will be prepared by Infectious Diseases physicians, and will be presented during one of the monthly departmental meetings, which routinely involve physician education. Ample time will be provided for answering questions from physicians. During the study period, the same material will be presented to new medical staff joining the department. The educational materials will be sent to all physicians in the department regardless of their attendance of the meeting. Patients will receive standard of care.

Behavioral: multifaceted antibiotic stewardship intervention

Group 2 wards (physician education + paper reminder)

ACTIVE COMPARATOR

For Group 2 wards, physician education will be provided as in Group 1. A paper reminder will be attached in the medical records of all consecutive patients on the first working day after Enterobacterale is isolated from blood culture. The reminder documents (1) the clinical and host criteria that should be considered for prescribing short-course antibiotic therapy, and (2) options of oral antibiotics to complete the treatment course. These recommendations are based on results of the trials demonstrating non-inferiority of short-course and oral-switch therapy for BSI-E.

Behavioral: multifaceted antibiotic stewardship intervention

Group 3 wards (multifaceted antibiotic stewardship intervention)

ACTIVE COMPARATOR

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.

Behavioral: multifaceted antibiotic stewardship intervention

Interventions

multifaceted antibiotic stewardship intervention BEHAVIORAL

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.

Group 1 wards (physician education); Group 2 wards (physician education + paper reminder); Group 3 wards (multifaceted antibiotic stewardship intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Infections

Central Study Contacts

Catherine Cheung

CONTACT

35053376; catherinecheung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head of Infectious Diseases, Department of Medicine & Therapeutics

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 13, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)