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

Last updated: May 6, 2024
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Treatment

Multiplex PCR assay (Film-array Pneumonia Panel Plus)

Lower tract respiratory samples

Lower respiratory tract standard culture

Clinical Study ID

NCT05952648
5768
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Suspicion of HAP/VAP (clinical/radiological/laboratory criteria);
  • Availability to perform tracheal aspirates or broncoalveolar lavage within 1 hour fromclinical suspicion
  • Life expectancy ≥ 48 hours
  • Signed written informed consent.

Exclusion

Exclusion Criteria:

  • Pregnancy,
  • Concomitant participating in other interventional trial
  • Refusal to sign informed consent

Study Design

Total Participants: 126
Treatment Group(s): 4
Primary Treatment: Multiplex PCR assay (Film-array Pneumonia Panel Plus)
Phase:
Study Start date:
April 03, 2024
Estimated Completion Date:
April 01, 2025

Study 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.

Connect with a study center

  • S. Orsola Research Hospital

    Bologna,
    Italy

    Site Not Available

  • Ospedale Careggi

    Firenze,
    Italy

    Site Not Available

  • Modena Policlinico

    Modena,
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario "A. GEMELLI" IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

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