HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 17, 2023
Trial Information
Current as of August 02, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new test called a semiquantitative multiplex PCR assay to see if it can help doctors quickly identify if critically ill patients have hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP). The goal is to find out if this new test can provide results faster than traditional methods, which could help doctors start the right treatment sooner and reduce unnecessary medications within the first 24 hours after pneumonia is suspected.
To be eligible for this trial, participants must be critically ill with signs suggesting they may have HAP or VAP, and they need to be able to undergo a specific procedure to collect lung samples within an hour of suspicion. Additionally, they should expect to live for at least 48 hours. The trial is open to all adults aged 65 and older, but pregnant individuals or those already in another trial cannot participate. Participants will need to provide written consent to join the study, and they can expect to receive close monitoring and care throughout the trial.
Gender
ALL
Eligibility 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
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Firenze, , Italy
Bologna, , Italy
Modena, , Italy
Roma, , Italy
Patients applied
Trial Officials
Gennaro De Pascale, MD
Principal Investigator
Fondazione Policlinico A. Gemelli IRCCS
Massimo Antonelli, MD
Study Chair
Fondazione Policlinico A. Gemelli IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported