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HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2024-04-03
Completion Date
2026-04-01
Last Updated
2025-08-14
Healthy Volunteers
No
Interventions
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
Multiplex PCR assay (Film-array Pneumonia Panel Plus)
The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
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)
Blood sample standard culture
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Locations (4)
S. Orsola Research Hospital
Bologna, Italy
Ospedale Careggi
Florence, Italy
Modena Policlinico
Modena, Italy
Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
Roma, Italy