Using a PCR test to diagnose pneumonia in critically ill patients
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
This study is testing a new PCR test to see if it can quickly and accurately diagnose pneumonia in critically ill patients to help them get the right treatment faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 4 sites (Bologna and 3 other locations) |
| Trial ID | NCT05952648 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled, open-label trial evaluates the effectiveness of a semiquantitative multiplex PCR assay in diagnosing hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) compared to conventional microbiology methods. The study aims to reduce the time to microbiological diagnosis within the first 24 hours of suspicion, which is crucial for timely and appropriate antibiotic treatment. By utilizing rapid molecular testing on respiratory samples, the trial seeks to facilitate early de-escalation of antibiotic therapy, thereby minimizing unnecessary antibiotic use and its associated risks. The trial will involve collecting lower respiratory tract samples and blood cultures from eligible patients.
Who should consider this trial
Good fit: Ideal candidates for this study are critically ill patients with suspected HAP or VAP who can undergo respiratory sampling within one hour of clinical suspicion.
Not a fit: Patients who are pregnant or currently participating in another interventional trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate pneumonia diagnoses, improving patient outcomes and reducing antibiotic misuse.
How similar studies have performed: Previous studies utilizing rapid molecular diagnostics for pneumonia have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Pregnancy, * Concomitant participating in other interventional trial * Refusal to sign informed consent
Where this trial is running
Bologna and 3 other locations
- S. Orsola Research Hospital — Bologna, Italy (Not_yet_recruiting)
- Ospedale Careggi — Florence, Italy (Not_yet_recruiting)
- Modena Policlinico — Modena, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario "A. GEMELLI" IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Gennaro De Pascale, MD — Fondazione Policlinico A. Gemelli IRCCS
- Study coordinator: Gennaro De Pascale, MD
- Email: gennaro.depascale@policlinicogemelli.it
- Phone: +393208998173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.