Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel in ICU Patients With Severe Pneumonia.

NCT ID: NCT05624684

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2024-02-22

Brief Summary

The objective of this study is to assess the diagnostic performance of multiplex respiratory PCR (PCR-RM) compared to standard microbiological tests and its potential impact on the early adaptation of antibiotic treatment in intensive care patients with severe pneumonia.

Detailed Description

This is a prospective, observational, multicenter ICU study. Adult patients with severe pneumonia requiring invasive mechanical ventilation will be included. Severe pneumonia consists of 3 categories of pneumonia: community-acquired pneumonia (CAP), hospital-acquired pneumonia (HAP), and ventilator-acquired pneumonia (VAP). The microbiological testing will be performed before antibiotic initiation on tracheobronchial aspirations, protected distal sampling, or mini-bronchoalveolar lavage as part of routine care. No additional samples will becollected for this study. Respiratory samples will be simultaneously tested by conventional microbiological techniques and multiplex respiratory PCR [PCR-RM] (BIOFIRE® FILMARRAY® Pneumonia Panel Plus). Classical microbiological culture (CMC) will be considered the gold standard for microbiological pneumonia diagnosis. The agreement between the results of the Pneumonia Plus® panel and the results of conventional microbial culture (CMC) will be assessed.

An empiric antibiotic therapy will be prescribed according to the local ecology and the protocols of each ICU unit. Two senior experts in each participating center will have to approve the antibiotic prescription. The antibiotic therapy could be modified after the reception of the Mutilpex PCR results by the two senior experts. After the reception of the results of the classic microbiological culture, the previous antibiotic changes will be judged as appropriate or inappropriate by a multidisciplinary team including intensivists, infectious disease specialists, and microbiologists. Appropriate changes include adequacy, de-escalation, and optimization of antibiotic therapy, and inappropriate changes include inadequacy, escalation, and de-optimization.

Conditions

Community-acquired Pneumonia; Hospital-acquired Pneumonia; Ventilator Associated Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICU patients with severe pneumonia

Critically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia.

Multiplex respiratory PCR

Intervention Type: DIAGNOSTIC_TEST

The BIOFIRE® FILMARRAY® Pneumonia plus Panel

Interventions

Multiplex respiratory PCR

The BIOFIRE® FILMARRAY® Pneumonia plus Panel

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• critically ill adult patients
• clinical, biological, and radiological signs of severe pneumonia.
• community-acquired pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
• invasive mechanical ventilation.

Exclusion Criteria

• Non-invasive mechanical ventilation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avicenna Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Younes Aissaoui, MD

Professor of Anesthesiology and Intensive Care Medicine - Head of surgical intensive care unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Avicenna Military Hospital

Marrakesh, Marrakesh Tensift El Haouz, Morocco

Countries

Morocco

Other Identifiers

MORICUP-PCR study

Identifier Type: -

Identifier Source: org_study_id