HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array (LIGHTNING)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: VAP - Ventilator Associated Pneumonia; HAP - Hospital Acquired Pneumonia

Treatments: Diagnostic Test: Lower respiratory tract standard culture; Diagnostic Test: Blood sample standard culture; Procedure: Lower tract respiratory samples; Diagnostic Test: Multiplex PCR assay (Film-array Pneumonia Panel Plus)

Study type: Interventional

Funder types: Other

Identifiers

NCT05952648

5768

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Film-array Pneumonia Panel Plus group

Experimental group

Description:

Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with new multiplex PCR assay (Film-array Pneumonia Panel Plus)

Treatment:

Procedure: Lower tract respiratory samples

Diagnostic Test: Lower respiratory tract standard culture

Diagnostic Test: Blood sample standard culture

Diagnostic Test: Multiplex PCR assay (Film-array Pneumonia Panel Plus)

Standard culture group (control group)

Active Comparator group

Description:

Patients with suspected HAP or VAP in which lower tract respiratory samples are analyzed with standard culture

Treatment:

Procedure: Lower tract respiratory samples

Diagnostic Test: Lower respiratory tract standard culture

Diagnostic Test: Blood sample standard culture