Ventilator Associated PneumoniaVAMPAIRNCT06554327
Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens
A study testing Multiplex PCR in people with Ventilator Associated Pneumonia, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- Multiplex PCR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2025to 4 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, hospitalized in intensive care unit
- on mechanical ventilation for at least 48 hours
- Suspected VAP
- With an indication for bronchoalveolar lavage (BAL)
Who cannot join
- Patients under legal protection or without social security coverage
- Pregnant women
- Previous episode of VAP during the same hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Antoine GOURY, 03 10 73 68 85 ext. 0033, agoury@chu-reims.fr
About this study
Official title: Fast Multiplex PCR of Bronchoalveolar Lavage for Antibiotic Stewardship in Ventilator Associated Pneumonia. A Multicenter, Randomized Controlled 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 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.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- Multiplex PCR
- Keywords
- Ventilator associated pneumonia, Intensive care unit, Empirical antimicrobial therapy, Multiplex PCR, Diagnosis, Antibiotic stewardship, Bronchoalveolar lavage
- Medical subject headings
- Pneumonia, Ventilator-Associated, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiplex PCRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Device: Multiplex PCR |
| control group | Active comparator | Not described Receives: Device: Multiplex PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (2)
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.
Measured: Day 14
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.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start6 Mar 2025
- Primary completion6 Sep 2030 (estimated)
- Study completion4 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554327
- Sponsor's protocol ID
- PR24072
- Acronym
- VAMPAIR
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Multiplex PCR of Bronchoalveolar Lavage for Antibiotic Stewardship in Ventilator Associated Pneumonia. A Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06554327
- Acronym / sponsor ID
- VAMPAIR / PR24072
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator associated pneumonia, Intensive care unit, Empirical antimicrobial therapy, Multiplex PCR, Diagnosis, Antibiotic stewardship, Bronchoalveolar lavage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 6 Sep 2030 (estimated)
- Study completion
- 4 Oct 2030 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: Multiplex PCR |
| control group | Active comparator | Device: Multiplex PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, hospitalized in intensive care unit
- on mechanical ventilation for at least 48 hours
- Suspected VAP
- With an indication for bronchoalveolar lavage (BAL)
Key exclusion criteria (3 listed)
- Patients under legal protection or without social security coverage
- Pregnant women
- Previous episode of VAP during the same hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiplex PCRIn 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. | Device | control group, intervention group |
Primary outcome
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.
2 secondary outcomes
The percentage of effective antibiotic treatment for the identified germ in each group.
Time frame: Day 14
Duration of inappropriate antibiotic therapy (in hours) in each group
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiplex PCR in people with Ventilator Associated Pneumonia, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine GOURY (03 10 73 68 85 ext. 0033, agoury@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.