HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Italy
S. Orsola Research Hospital
NOT_YET_RECRUITING
Bologna
Ospedale Careggi
NOT_YET_RECRUITING
Florence
Modena Policlinico
NOT_YET_RECRUITING
Modena
Fondazione Policlinico Universitario A. GEMELLI IRCCS
RECRUITING
Roma
Contact Information
Primary
Gennaro De Pascale, MD
gennaro.depascale@policlinicogemelli.it
+393208998173
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 126
Treatments
Experimental: Film-array Pneumonia Panel Plus group
Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus)
Active_comparator: Standard culture group (control group)
Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture
Related Therapeutic Areas
Sponsors
Collaborators: Catholic University of the Sacred Heart
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS