Antimicrobial Stewardship for Enterobacterales Bacteremia Management

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Percentage of patients receiving 7 days effective antibiotic therapy for the treatment of BSI-E [Срок оценки: 7 days]

Вторичные конечные точки (5)

• proportion of patients with susceptible oral antibiotics completed the course with an oral antibiotic [Срок оценки: during hopsitalization]
• 30-day all-cause mortality [Срок оценки: 30 day since hospital admission]
• clinical failure [Срок оценки: within 90 days since hopsitalization]
• length of stay in hospital [Срок оценки: from the admission up to the discharge]
• re-admission to hospital within 90 days [Срок оценки: within 90 days since discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Prince of Wales Hospital — Shatin

Идентификаторы

NCT: NCT06257147 · ASP BSI Protocol

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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