BLOOM: Pragmatic Feasibility Trial

Обзор

The goal of this study is to compare two different ways of dosing cefepime, an antibiotic for very sick patients - the usual approach to dosing or a new dosing method. The new dosing method uses only doses that are available in normal care, but choosing between the different doses is based on more information about the patient's body including their kidney function. The primary purpose of this study is to test how easy it is for healthcare professionals to use the new dosing method and how best to conduct the trial. The study will also assess if the new dosing method helps patients recover faster and reduces side effects.

Вмешательства

• Другое Up-front individualized dosing algorithm
  An individualized cefepime dosing algorithm will be used to determine the cefepime dose and interval. The dose recommendation will be provided using the EHR-prompts to the clinical care team and ordered and/or verified by the ICU pharmacist using an established collaborative practice agreement. As a pragmatic trial, at any point care teams may modify the empiric or subsequent dose based on their clinical judgement.
• Другое Usual Care
  The standard of care group will receive empiric dosing guided by an institutional antimicrobial guide. Cefepime is typically dosed at 0.5-2 g every 8-24 h according to categorical thresholds of estimated creatinine clearance (eGFRcr). Cystatin C and eGFRcr-cys can be calculated and used at clinicians' discretion to aid in drug dose determination.

Первичные конечные точки

• Proportion of patients screened who qualified for the study [Срок оценки: 1 year or once the sample size is achieved]
• Distribution of qualified patients across care teams [Срок оценки: 1 year or once the sample size is achieved]
• Adherence to dosing recommendations [Срок оценки: 1 year or once the sample size is achieved]

Вторичные конечные точки (6)

• Number of antibiotic-free days [Срок оценки: 28-days]
• ICU length of stay [Срок оценки: 1 year]
• Proportion of patients who experience new anti-Pseudomonal beta-lactam resistance [Срок оценки: 6 months]
• Proportion of patients who experience clinical success [Срок оценки: 8 days]
• Proportion of patients who experience microbiologic success [Срок оценки: 8 days]
• Mortality [Срок оценки: 28-days]

Критерии участия

Критерии включения

• Adults ≥18 years of age
• Admitted to one of the ICUs at the study center
• Prescribed cefepime therapy by the care team

Критерии исключения

• Individuals will be those with a cephalosporin allergy
• Received >1 dose of cefepime in the 24 hours before ICU admission
• Transferred from an external hospital without compatible EHR
• Does not have a cystatin C and a creatinine available for drug dosing
• Acute kidney injury stage 2 or higher
• Receiving renal replacement therapy
• Treated with extracorporeal membrane oxygenation
• Undergoing molecular adsorbent recirculating therapy at the time of beta-lactam initiation
• Pregnant
• Incarcerated
• Declined Minnesota research authorization

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Rochester — Rochester

Публикации

• Barreto EF, Scheetz MH, Chang J, Cole KC, Fogelson LA, Paul J, Jannetto PJ, Gajic O, Rule AD; Beta Lactam Optimization and Outcomes Management (BLOOM) Study Group. Cystatin C-Guided Dosing Nomogram Improves Target Attainment for Cefepime in the Critically Ill. Crit Care Med. 2025 Apr 1;53(4):e941-e952. doi: 10.1097/CCM.0000000000006622. Epub 2025 Feb 27. PMID 40013864

Идентификаторы

NCT: NCT07287332 · 25-004564

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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