Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens (VAMPAIR)

Fast Multiplex PCR of Bronchoalveolar Lavage for Antibiotic Stewardship in Ventilator Associated Pneumonia. A Multicenter, Randomized Controlled Study

Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect DNA of a number of bacteriae, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.

Study Overview

• Status: Recruiting
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Device: Multiplex PCR

Detailed Description

Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect the bacterial DNA of a number of bacteria, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.

The aim of our study is to compare the percentage of appropriate empirical antibiotic therapy in the group benefiting from multiplex PCR on BAL prior to bacterial culture results compared to control group (bacterial culture alone=usual management) in patients with culture-confirmed VAP.

This is a multicenter, randomized, controlled, French study conducted in 8 university intensive care units (2 surgical units, 6 medical units) in the Grand-Est region of France. The multiplex PCR tested here is BioFire's FilmArray Pneumonia Panel Plus. It is performed solely on per-fibroscopic bronchoalveolar lavage (BAL) fluids in cases of suspected VAP.

• Study Type: Interventional
• Enrollment (Estimated): 265
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine GOURY; Phone Number: 0033 03 10 73 68 85; Email: agoury@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Recruiting
    • Damien JOLLY
    • Contact: Antoine GOURY; Phone Number: 0033 03 10 73 68 85; Email: agoury@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

inclusion criteria :

• Adult patients, hospitalized in intensive care unit
• on mechanical ventilation for at least 48 hours
• Suspected VAP
• With an indication for bronchoalveolar lavage (BAL)

exclusion criteria :

• Patients under legal protection or without social security coverage
• Pregnant women
• Previous episode of VAP during the same hospitalization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Device: Multiplex PCR; In the intervention group (Multiplex PCR performed and results communicated to the clinician), bronchoalveolar lavage will be examined directly after Gram staining by the laboratory, followed by quantitative culture. A multiplex PCR will be performed.
Experimental: intervention group	Device: Multiplex PCR; In the intervention group (Multiplex PCR performed and results communicated to the clinician), bronchoalveolar lavage will be examined directly after Gram staining by the laboratory, followed by quantitative culture. A multiplex PCR will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of appropriate empirical antibiotic therapy in cases of culture-confirmed VAP, according to the diagnostic method used (multiplex PCR or not).	The appropriate antibiotic is one that is effective against the diagnosed pathogen and has the narrowest possible antibiotic spectrum.	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of effective antibiotic treatment for the identified germ in each group.	The effective antibiotic is one that is effective against the diagnosed pathogen.	Day 14
Duration of inappropriate antibiotic therapy (in hours) in each group	An inappropriate antibiotic is one that is not active according to the in vitro antibiogram of the identified pathogen, or whose spectrum is too broad for the resistance profile of the identified pathogen.	Day 14

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): October 6, 2026

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Intensive care unit; Diagnosis; Bronchoalveolar lavage; Ventilator associated pneumonia; Multiplex PCR; Antibiotic stewardship; Empirical antimicrobial therapy
• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Cross Infection; Iatrogenic Disease; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: PR24072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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