Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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