Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05952648

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

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-14

126

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead Sponsor

C

Catholic University of the Sacred Heart

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspicion of hospital-acquired pneumonia or ventilator-associated pneumonia based on clinical, radiological, or laboratory criteria
  • Ability to perform tracheal aspirates or bronchoalveolar lavage within 1 hour of clinical suspicion
  • Life expectancy of 48 hours or more
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Participation in another interventional clinical trial
  • Refusal to sign informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

S. Orsola Research Hospital

Bologna, Italy

Not Yet Recruiting

2

Ospedale Careggi

Florence, Italy

Not Yet Recruiting

3

Modena Policlinico

Modena, Italy

Not Yet Recruiting

4

Fondazione Policlinico Universitario "A. GEMELLI" IRCCS

Roma, Italy, 00168

Actively Recruiting

Loading map...

Research Team

G

Gennaro De Pascale, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here