Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens

NCT06554327 | Recruiting

• 1 other identifier: PR24072
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventilator Associated Pneumonia

Keywords

Ventilator associated pneumonia; Intensive care unit; Empirical antimicrobial therapy; Multiplex PCR; Diagnosis; Antibiotic stewardship; Bronchoalveolar lavage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The percentage of effective antibiotic treatment for the identified germ in each group.

  Day 14

• Duration of inappropriate antibiotic therapy (in hours) in each group

  Day 14

Study Arms (2)

intervention group

EXPERIMENTAL

Device: Multiplex PCR

control group

ACTIVE COMPARATOR

Device: Multiplex PCR

Interventions

Multiplex PCR DEVICE

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.

control group; intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Disease

Interventions

Multiplex Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Central Study Contacts

Antoine GOURY

CONTACT

03 10 73 68 85; agoury@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): October 6, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)