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 groupsSponsors and collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Catholic University of the Sacred Heart
Collaborator
Source ClinicalTrials.gov