Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - Pregnancy, - Concomitant participating in other interventional trial - Refusal to sign willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Lower tract respiratory samples

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

DIAGNOSTIC_TEST

Multiplex PCR assay (Film-array Pneumonia Panel Plus)

The lower tract respiratory samples will be analyzed with Multiplex PCR assay (Film-array Pneumonia Plus).

DIAGNOSTIC_TEST

Lower respiratory tract standard culture

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)

DIAGNOSTIC_TEST

Blood sample standard culture

When HAP or VAP are suspected, blood samples from peripheral vein will be collected and analyzed with conventional microbiological methods

Locations (4)

S. Orsola Research Hospital
Bologna, Italy
Ospedale Careggi
Florence, Italy
Modena Policlinico
Modena, Italy
Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
Roma, Italy