Antimicrobial Stewardship for Enterobacterales Bacteremia Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: multifaceted antibiotic stewardship intervention.
- Who it may be relevant to
- Registry conditions: Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 wi
Primary outcome measures
- Percentage of patients receiving 7 days effective antibiotic therapy for the treatment of BSI-E [Time frame: 7 days]
Secondary outcome measures (5)
- proportion of patients with susceptible oral antibiotics completed the course with an oral antibiotic [Time frame: during hopsitalization]
- 30-day all-cause mortality [Time frame: 30 day since hospital admission]
- clinical failure [Time frame: within 90 days since hopsitalization]
- length of stay in hospital [Time frame: from the admission up to the discharge]
- re-admission to hospital within 90 days [Time frame: within 90 days since discharge]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Shatin
Identifiers
NCT: NCT06257147 · ASP BSI Protocol