HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Pregnancy,
Concomitant participating in other interventional trial
Refusal to sign informed consent
Trial design
Treatments tested in this trial
- Lower tract respiratory samples
- Multiplex PCR assay (Film-array Pneumonia Panel Plus)
- Lower respiratory tract standard culture
- Blood sample standard culture
Treatment groups
126 Participants
are divided into 2 treatment groupsLocations
4S. Orsola Research Hospital Bologna Italy
Ospedale Careggi Florence Italy
Modena Policlinico Modena Italy
Fondazione Policlinico Universitario "A. GEMELLI" IRCCS00168, Roma Italy
Sponsors and collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Catholic University of the Sacred Heart
Collaborator
Source ClinicalTrials.gov