HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
126 participants
Apr 3, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- Pregnancy,
- Concomitant participating in other interventional trial
- Refusal to sign informed consent
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Interventions
Within 1 hour from HAP or VAP suspicion, quantitative tracheal aspirate or bronchoalveolar lavage will be performed to confirm the diagnosis. Clinicians will be encouraged to perform BAL whenever possible
The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).
The lower tract respiratory samples will be analyzed using convention microbiological methods (including conventional Gram stain and semiquantitative culture on both selective/differential and screening agar media)
When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05952648