An interventional study of multifaceted antibiotic stewardship intervention in Infections, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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:
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 420 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
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
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 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
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.
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
Time frame: 7 days
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
Time frame: during hopsitalization
30-day all-cause mortality
30-day all-cause mortality
Time frame: 30 day since hospital admission
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
Time frame: within 90 days since hopsitalization
length of stay in hospital
length of stay in hospital
Time frame: from the admission up to the discharge
re-admission to hospital within 90 days
re-admission to hospital within 90 days
Time frame: within 90 days since discharge
Plan to share: No
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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong