Clinical trial NCT05952648: HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
Official title: HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Assay: A Multicenter Randomized Open-Label Trial. THE LIGHTNING STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HAP - Hospital Acquired Pneumonia
VAP - Ventilator Associated Pneumonia
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2023-07-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, multicenter, open-label trial
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Hospital-acquired pneumonia and ventilator-associated pneumonia are leading cause of morbidity and mortality in Intensive Care Unit due to the underlining clinical conditions of critically ill patients and the high rate of multidrug resistance among causative agents.

In patients with sepsis and septic shock, early and appropriate antibiotics are essential for improving clinical outcome, often requiring the use of broad-spectrum combinations.

The optimal use of antimicrobials is part of current implementation programs aimed to reduce the administration of not-necessary antibiotics, the bio-ecologic pressure and the possible side effects .

In this context the application of rapid, molecular microbiological tests on respiratory samples is of overwhelming interest, due to the potential of reducing the time to inappropriate antibiotic therapy and of prompting de-escalation.

During last years a new Multiplex PCR Assay for pneumonia diagnosis (Film-Array Pneumonia Panel Plus, BioFire, Salt Lake City, UT, USA) has been implementing in the clinical practice, showing very high rates of negative and positive predictive values.

The hypothesis is that molecular test on lower respiratory tract samples may reduce the time to microbiological diagnosis, thus allowing early antibiotic de-escalation.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients without microbiological diagnosis of HAP/VAP within the first 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of antibiotic de-escalation as a consequence of microbiological results
timeFrame: 4 days
measure: Time to antibiotic de-escalation and optimal therapy
timeFrame: 4 days
measure: Mechanical Ventilation free-days
timeFrame: 14 and 28 days
measure: Rate of MDR infection
timeFrame: 28 days
measure: Lenght of intensive care unit stay
timeFrame: 60 days
measure: Lenght of hospital stay
timeFrame: 60 days
measure: In-Intensive care unit mortality
timeFrame: 28 days and 60 days
measure: 28 days and 60 days mortality
timeFrame: 28 days and 60 days
measure: SOFA score
timeFrame: 14 days
measure: Diagnostic concordance
timeFrame: 4 days
measure: Adverse event
timeFrame: 28 days
measure: In-Hospital mortality
timeFrame: 28 days and 60 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S. Orsola Research Hospital
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Modena
country: Italy
facility: Modena Policlinico
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario "A. GEMELLI" IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Gennaro De Pascale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Massimo Antonelli, MD
role: STUDY_CHAIR
References: