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

NCT05952648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2025-08-14

No results posted yet for this 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.

Conditions

  • HAP - Hospital Acquired Pneumonia
  • VAP - Ventilator Associated Pneumonia

Interventions

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

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Gennaro De Pascale, MD · Fondazione Policlinico A. Gemelli IRCCS

  • Massimo Antonelli, MD · Fondazione Policlinico A. Gemelli IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05952648 on ClinicalTrials.gov