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

Diagnostic Performance and Impact of a Multiplex PCR Pneumonia Panel on the Early Adaptation of Antimicrobial Therapy in ICU Patients With Severe Pneumonia. A Prospective Multicentric Observational Study.

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.

Study Overview

• Status: Completed
• Conditions: Hospital-acquired Pneumonia; Ventilator Associated Pneumonia; Community-acquired Pneumonia
• Intervention / Treatment: Diagnostic test: Multiplex respiratory PCR

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.

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

• Study Contact: Name: Younes Aissaoui, MD; Phone Number: +212661403332; Email: younes.aissaoui@live.fr
• Study Contact Backup: Name: Ayoub Belhadl, MD; Phone Number: +212670279562; Email: ayoubbelhadj@gmail.com

Study Locations

• Morocco
  • Marrakesh Tensift El Haouz
    • Marrakesh, Marrakesh Tensift El Haouz, Morocco, 40000
      • Avicenna Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill patients with ventilator-associated pneumonia (VAP), community-acquired pneumonia (CAP), or hospital-acquired pneumonia (HAP). For CAP and HAP, only patients under invasive mechanical ventilation will be included.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICU patients with severe pneumonia; Critically ill patients with severe pneumonia under mechanical ventilation including ventilator-associated pneumonia, community-acquired or hospital-acquired pneumonia.	Diagnostic test: Multiplex respiratory PCR; The BIOFIRE® FILMARRAY® Pneumonia plus Panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of diagnostic concordance between Classical microbiological cultures and the respiratory multiplex PCR (RM-PCR) and conventional microbiological cultures (CMC) to identify pathogens responsible for severe pneumonia in critically ill patients.	Classical microbiological cultures (CMC) will serve as the gold standard for the comparison between techniques, considering a test result: A true positive, when CMC and RM-PCR have identified the same microorganism (CMC+, PCR-RM +).; A false positive, when RM-PCR detected an organism but not CMC (CMC-, RM-PCR+); A true negative, when no method detected any microorganism (CMC-, RM-PCR -); A false negative, when CMC but not RM-PCR has detected an organism (CMC+, RM-PCR -). Sensitivity, specificity, and positive and negative predictive values for the respiratory multiplex PCR will be calculated using the precedent findings.	through study completion, an average of 6 months
The impact of the respiratory multiplex PCR (RM-PCR) on the appropriateness of empirical antimicrobial therapy.	The proportion of patients for whom the respiratory multiplex PCR (RM-PCR) induces an appropriate change of antibiotic therapy. Appropriate changes include adequacy, de-escalation, and escalation of antibiotic treatment.; Adequacy is defined as introducing an antibiotic to cover a microorganism that was not adequately treated before the results of RM-PCR.; Escalation is defined by a widening of the ATB spectrum to cover a pathogen not taken into account or the detection of resistance genes.; De-escalation is defined as the use of a narrower-spectrum anti-infective or the discontinuation of an ATB combination.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Avicenna Military Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): February 22, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Ventilator Associated Pneumonia; Community-acquired Pneumonia; Multiplex PCR; Antibiotic stewardship; Hospital-acquired Pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: MORICUP-PCR study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets of the study will be available from the principal investigator on reasonable request.
• IPD Sharing Time Frame: until 5 years after study completion
• IPD Sharing Access Criteria: Healthcare workers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No