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Search / Trial NCT05952648

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.

Locations

Firenze, , Italy

Bologna, , Italy

Modena, , Italy

Roma, , Italy

Patients applied

0 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