Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU

Официальное название

Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units

Обзор

The goal of this randomized clinical trial is to determine whether a biomarker-signature (BV) supported antibiotic treatment decision matrix can have a beneficial impact on antibiotic use and patient outcomes in an ICU population.

Подробное описание

This study will pragmatically combine the evaluation of a diagnostic test with an antibiotic treatment decision matrix, in a manner that mimics real-life but is as close as possible to a "best-case" scenario.

Primary objective is to evaluate the combined endpoint of efficacy and safety at 28 days (approximately 4 weeks). This will include:

* Efficacy: Assessed by the use of antibiotics. * Safety: Assessed by clinical outcomes.

Eligible participants will be randomized 1:1 to either the intervention or control groups. Evaluation of safety and efficacy will be combined to provide a global evaluation of the benefits and risks of the intervention, using the Desirability of Outcome Ranking (DOOR) further combined with Response Adjusted for Duration of Antibiotic Risk (RADAR).

The hypothesis is that participants in the intervention group will have lower antibiotic exposure, without increased harm (worse clinical outcomes related to infection or significant adverse events) .

Вмешательства

• Диагностический тест Biomarker-signature supported antibiotic treatment recommendation
  The antibiotic treatment recommendation will be based on a decision matrix that combines the results of the BV-signature (a score ranging from 0 -100) with the clinical assessment of likelihood of bacterial infection.
• Диагностический тест Clinical assessment for antibiotic treatment decision
  Antibiotic treatment decision will be based on clinical assessment only (BV test result remains masked)

Первичные конечные точки

• Desirability of Outcome Ranking Adjusted for Antibiotic Risk (DOOR-RADAR) [Срок оценки: 28 days+/- 2]

Вторичные конечные точки (5)

• All cause mortality [Срок оценки: 28 +/- 2 days]
• Days of antibiotic therapy (DOT) [Срок оценки: 28 +/- 2 days]
• Antibiotic-free days [Срок оценки: 28 days+/- 2]
• Adverse events [Срок оценки: 28 +/- 2 days]
• Length of stay in the Intensive Care Unit [Срок оценки: 28 +/- 2 days]

Критерии участия

Критерии включения

• Admitted to the Intensive Care Unit (ICU)
• Started on antibiotics for any suspected or confirmed infection in the preceding 72 hours (about 3 days)
• Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making

Критерии исключения

• Severe immunocompromise/immunosuppression

• Congenital immunodeficiency
• HIV with CD4 < 20
• Active chemotherapy and profound neutropenia (ANC < 100) expected to last > 7 days;
• solid organ or stem cell transplant within preceding 6 months AND active GVHD
• Receiving high dose steroids (Pred > 20mg/day for > or = 2 weeks)
• Advanced metastatic cancer irrespective of treatment
• Palliative intent, death imminent and inevitable within 4 weeks
• Antibiotic to be discontinued within 24h (ex. Prophylaxis)
• Active infection diagnosed and treated with antibiotics within preceding 2 weeks
• Previously included during the same hospitalization

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

Канада · 4 центра

• Montreal General Hospital — Montreal
• Research Institute of McGill University Health Center (RI-MUHC) — Montreal
• Royal Victoria Hospital — Montreal
• Research Institute McGill University Health Centre — Montreal

Идентификаторы

NCT: NCT07481773 · 2025-10747 · FRN 194227

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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