Antimicrobial Stewardship for Enterobacterales Bacteremia Management

Sponsor
Chinese University of Hong Kong
Study ID
NCT06257147
Status
Not Yet Recruiting

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Conditions

  • Infections

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

First listed
Feb 13, 2024
Start date
May 1, 2024
Status verified
Mar 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group 1 wards (physician education)
    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.
  • Active Comparator: Group 2 wards (physician education + paper reminder)
    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.
  • Active Comparator: Group 3 wards (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.

Primary Outcome Measure

Percentage of patients receiving 7 days effective antibiotic therapy for the treatment of BSI-E [ Time Frame: 7 days ]

Central Contacts

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