HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array

Официальное название

HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY

Обзор

Multicenter, randomized, controlled, open-label trial to assess if semiquantitative multiplex PCR assay, as compared to conventional microbiology, can reduce the percentage of patients without microbiological diagnosis in the first 24 hours from HAP/VAP suspicion, thus allowing early de-escalation.

Подробное описание

Hospital-acquired pneumonia and ventilator-associated pneumonia are leading cause of morbidity and mortality in Intensive Care Unit due to the underlining clinical conditions of critically ill patients and the high rate of multidrug resistance among causative agents.

In patients with sepsis and septic shock, early and appropriate antibiotics are essential for improving clinical outcome, often requiring the use of broad-spectrum combinations.

The optimal use of antimicrobials is part of current implementation programs aimed to reduce the administration of not-necessary antibiotics, the bio-ecologic pressure and the possible side effects .

In this context the application of rapid, molecular microbiological tests on respiratory samples is of overwhelming interest, due to the potential of reducing the time to inappropriate antibiotic therapy and of prompting de-escalation.

During last years a new Multiplex PCR Assay for pneumonia diagnosis (Film-Array Pneumonia Panel Plus, BioFire, Salt Lake City, UT, USA) has been implementing in the clinical practice, showing very high rates of negative and positive predictive values.

The hypothesis is that molecular test on lower respiratory tract samples may reduce the time to microbiological diagnosis, thus allowing early antibiotic de-escalation.

Вмешательства

• Процедура Lower tract respiratory samples
  Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible
• Диагностический тест Multiplex PCR assay (Film-array Pneumonia Panel Plus)
  The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
• Диагностический тест Lower respiratory tract standard culture
  The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective/differential and screening agar media)
• Диагностический тест Blood sample standard culture
  When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods

Первичные конечные точки

• Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours [Срок оценки: 24 hours]

Вторичные конечные точки (12)

• Rate of antibiotic de-escalation as a consequence of microbiological results [Срок оценки: 4 days]
• Time to antibiotic de-escalation and optimal therapy [Срок оценки: 4 days]
• Mechanical Ventilation free-days [Срок оценки: 14 and 28 days]
• Rate of MDR infection [Срок оценки: 28 days]
• Lenght of intensive care unit stay [Срок оценки: 60 days]
• Lenght of hospital stay [Срок оценки: 60 days]
• In-Intensive care unit mortality [Срок оценки: 28 days and 60 days]
• 28 days and 60 days mortality [Срок оценки: 28 days and 60 days]
• SOFA score [Срок оценки: 14 days]
• Diagnostic concordance [Срок оценки: 4 days]
• Adverse event [Срок оценки: 28 days]
• In-Hospital mortality [Срок оценки: 28 days and 60 days]

Критерии участия

Критерии включения

• Suspicion of HAP/VAP (clinical/radiological/laboratory criteria);
• Availability to perform tracheal aspirates or broncoalveolar lavage within 1 hour from clinical suspicion
• Life expectancy ≥ 48 hours
• Signed written informed consent.

Критерии исключения

• Pregnancy,
• Concomitant participating in other interventional trial
• Refusal to sign informed consent

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

Диагностика

Центры проведения

Италия · 4 центра

• S. Orsola Research Hospital — Bologna
• Ospedale Careggi — Florence
• Modena Policlinico — Modena
• Fondazione Policlinico Universitario "A. GEMELLI" IRCCS — Roma

Идентификаторы

NCT: NCT05952648 · 5768

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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