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

VAP - Ventilator Associated Pneumonia Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• VAP - Ventilator Associated Pneumonia

• NCT number: NCT05952648
• Study type: Interventional
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Gennaro De Pascale, MD
• Phone: +393208998173
• Email: gennaro.depascale@policlinicogemelli.it
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Completion date: April 1, 2025