Clinical trial NCT06554327: Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens
Official title: Fast Multiplex PCR of Bronchoalveolar Lavage for Antibiotic Stewardship in Ventilator Associated Pneumonia. A Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Associated Pneumonia
Keywords: Ventilator associated pneumonia
Intensive care unit
Empirical antimicrobial therapy
Multiplex PCR
Diagnosis
Antibiotic stewardship
Bronchoalveolar lavage
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The percentage of appropriate empirical antibiotic therapy in cases of culture-confirmed VAP, according to the diagnostic method used (multiplex PCR or not).
timeFrame: Day 14
Secondary outcomes:
measure: The percentage of effective antibiotic treatment for the identified germ in each group.
timeFrame: Day 14
measure: Duration of inappropriate antibiotic therapy (in hours) in each group
timeFrame: Day 14
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: