HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array

Recruiting now · Not applicable

Conditions studied: HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia

In brief

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.

Key facts

Study ID

NCT05952648

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

126

Starts

2024-04-03

Expected to finish

2026-04-01

Last updated by the study team

2025-08-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnancy,
• Concomitant participating in other interventional trial
• Refusal to sign informed consent

Where it is running

• Fondazione Policlinico Universitario "A. GEMELLI" IRCCS — Roma, Italy (enrolling)
• S. Orsola Research Hospital — Bologna, Italy
• Ospedale Careggi — Florence, Italy
• Modena Policlinico — Modena, Italy

Full record on ClinicalTrials.gov

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