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

What this Trial Is About

Researchers are evaluating a new molecular test called the Multiplex PCR assay (Film-array Pneumonia Panel Plus) for diagnosing hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) in critically ill septic patients. These lung infections cause serious health problems in intensive care units, especially due to multidrug-resistant bacteria. The study aims to find out if this rapid test can reduce the number of patients without a microbiological diagnosis within 24 hours of suspicion, allowing earlier adjustment of antibiotics compared to conventional microbiology methods. The trial compares two groups of patients suspected of HAP or VAP. One group will have their lower respiratory tract samples analyzed using the new Multiplex PCR assay, while the other group will have standard culture tests. Samples will be collected within one hour of suspicion through quantitative tracheal aspirate or bronchoalveolar lavage. Blood samples will also be analyzed using conventional methods. The study is randomized and open-label, conducted at multiple centers. Participants will undergo respiratory sample collection and blood draws soon after pneumonia suspicion. Researchers will monitor how quickly microbiological diagnoses are made and track antibiotic changes, ventilator-free days, infection rates, length of hospital and ICU stays, mortality, and organ failure scores over several weeks. Safety and diagnostic accuracy will also be assessed. The study will follow participants for up to 60 days to evaluate outcomes and effects of the diagnostic methods.

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