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RecruitingNCT06554327VAMPAIRUpdated Sep 3, 2026

Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens

An interventional study of Multiplex PCR in Ventilator Associated Pneumonia, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by CHU de Reims · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
265
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • Ventilator associated pneumonia
  • Intensive care unit
  • Empirical antimicrobial therapy
  • Multiplex PCR
  • Diagnosis
  • Antibiotic stewardship
  • Bronchoalveolar lavage
03

In context

Pneumonia, Ventilator-Associated

420 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 85 are open to participants now.

This study's planned enrollment of 265 is above the median of 115 across 276 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

exclusion criteria :

  • Patients under legal protection or without social security coverage
  • Pregnant women
  • Previous episode of VAP during the same hospitalization
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
265 participants (estimated)

Study arms

  • Experimental
    intervention group

    Device: Multiplex PCR

  • Active comparator
    control group

    Device: Multiplex PCR

Interventions

  • DeviceMultiplex 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.

06

What researchers measure

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.

    Time frame: Day 14

Secondary outcomes

  1. 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.

    Time frame: Day 14

  2. 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.

    Time frame: Day 14

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Sep 2030, 66 months after the start.

Of 81 non-industry interventional studies with no phase under Pneumonia, Ventilator-Associated, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 66 months is above that.

Counting every sponsor, half of 82 studies reached it within 20 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2024
First posted
Aug 15, 2024
StartActual
Mar 6, 2025
Primary completionEst.
Sep 6, 2030
CompletionEst.
Oct 4, 2030
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06554327
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Aug 15, 2024
Start date
Mar 6, 2025
Primary completion
Sep 6, 2030 (estimated)
Completion
Oct 4, 2030 (estimated)
Last update
Sep 3, 2026

Study contacts

Antoine GOURY
Contact
agoury@chu-reims.fr
03 10 73 68 85 ext. 0033

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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