HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
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.
| Condition(s) | HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * Pregnancy, * Concomitant participating in other interventional trial * Refusal to sign informed consent |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Locations | Bologna, Italy; Florence, Italy; Modena, Italy; Roma, Italy |
| Start date | 2024-04-03 |
| NCT ID | NCT05952648 |
| Official listing | https://clinicaltrials.gov/study/NCT05952648 |