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

C

CHU de Reims

Status

Not yet enrolling

Conditions

Ventilator Associated Pneumonia

Treatments

Device: Multiplex PCR

Study type

Interventional

Funder types

Other

Identifiers

NCT06554327
PR24072

Details and patient eligibility

About

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.

Full 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.

Enrollment

265 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

265 participants in 2 patient groups

intervention group
Experimental group
Treatment:
Device: Multiplex PCR
control group
Active Comparator group
Treatment:
Device: Multiplex PCR

Trial contacts and locations

1

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Central trial contact

Antoine GOURY

Data sourced from clinicaltrials.gov

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