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NCT Number: NCT06554327

Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

    Time frame: Day 14

    The appropriate antibiotic is one that is effective against the diagnosed pathogen and has the narrowest possible antibiotic spectrum.

Secondary outcomes

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

    Time frame: Day 14

    The effective antibiotic is one that is effective against the diagnosed pathogen.

  2. Duration of inappropriate antibiotic therapy (in hours) in each group

    Time frame: Day 14

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine GOURY

CONTACT

[email protected]

03 10 73 68 85 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study title

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

Acronym: VAMPAIR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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