Ventilator Associated Pneumonia ( VAP)Phase 4SMART-VAPNCT07403474
Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia
A Phase 4 study testing strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology in people with Ventilator Associated Pneumonia ( VAP), run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
Assess the impact of a strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for ventilator-associated pneumonia (VAP) (intervention), compared to a conventional strategy (control). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia ( VAP)
- What is being tested?
- strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Mar 2026to 27 Apr 2028
- Phase
- Phase 4
- 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
- Adults (≥18 years) with VAP (mechanical ventilation and hospitalization ≥ 48 hours) and deep respiratory sample by mini BAL < 12 hours. The diagnosis of pneumonia includes two clinical criteria among fever (≥38.3°C), purulent sputum or aspiration, hyperleukocytosis (>12,000 WBC/mm³) or leukopenia (<4,000 WBC/mm³), hypoxemia, auscultatory signs in the affected area, and a newly-appeared parenchymal infiltrate
- Patient receiving initial probabilistic antibiotic therapy for VAP suspicion
- Informed consent or emergency procedure
- Patient affiliated with or beneficiary of a health insurance plan.
- Non inclusion Criteria:
- Pregnancy
Show all 16Show fewer
- Congenital immunodeficiency;
- HIV infection with the lymphocyte CD4 count below 200/mm3 or unknown in the last year;
- Acute hematologic malignancy;
- Neutropenia (<1 leucocyte/mL or < 0.5 neutrophil/mL);
- Immunosuppressive drugs within the previous 30 days, including anti-cancer - Chemotherapy and anti-rejection drugs for organ/bone marrow transplant
- Corticosteroids ≥ 20 mg/d of prednisone equivalent for more than 14 days
- Known allergy to beta-lactams
- Moribund patient or death expected from underlying disease during the current admission;
- Patient deprived of liberty or under legal protection measure;
- Participation in another interventional trial.
Who cannot join
- mPCR non available
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CH ALES
Alès, 30100
Lauren BEAUDEAU, MD, +33 4 66 78 32 06, dr.beaudeau@ch-ales.fr
Lauren BEAUDEAU, MD
- Recruiting
CHU Nîmes
Nîmes, 34070
Hugo Martiniere, PH, + 33 6 68 68 33 31, hugo.martiniere@chu-nimes.fr
Hugo Martiniere, MD
About this study
Official title: Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia : a Bicentric, Parallel-group, Randomized Controlled Trial.
Assess the impact of a strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for ventilator-associated pneumonia (VAP) (intervention), compared to a conventional strategy (control).
A bicentric, parallel-group, randomized controlled trial. The primary assessment criterion is the proportion of early optimized antibiotic therapy within 24 hours of respiratory sampling.
Read the detailed description
In both arms, for eligible patients with VAP, a deep respiratory sample collection is performed prior to inclusion. This collection is carried out either by mini bronchoalveolar lavage (BAL) via bronchoscopy or by blind mini BAL in alignment with the protocolized procedure. Initial antibiotic therapy is initiated after the deep sample has been taken according to the discretion of the attending clinician and in accordance with good practice recommendations. Both groups have their samples analyzed using conventional techniques. First, there is a direct examination, followed by culture and susceptibility testing, which is used as the gold standard technique for evaluating the primary endpoint.
In the intervention arm, in addition to conventional techniques, a broad-panel respiratory mPCR is performed before the 12th hour following achievement of the deep respiratory sample on the collected BAL. Once the mPCR results are received, the clinician adjusts the initial antibiotic therapy using algorithm-based therapy developed using local epidemiology in order to optimize treatment as early as possible.
In the control arm, the strategy is based on the clinician's choice in accordance with best practice recommendations without the combined use of respiratory mPCR and algorithm-based therapy. The deep respiratory sample is analyzed using conventional methods. Initial antibiotic treatment is therefore adapted by the clinician in charge of the patient according to departmental practices based on best practice recommendations, taking into account the results of the direct examination, culture, and susceptibility testing.
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Being tested
- strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology
- Keywords
- mPCR, ventilator associated pneumonia, algorithm-based therapy
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiologyProcedure or surgery
strategy combining respiratory mPCR carried out either by mini bronchoalveolar lavage (BAL) via bronchoscopy or by blind mini BAL, and algorithm-based therapy developed using local epidemiology for the early optimization of initial antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| combined use of mPCR and algorithm-based therapy | Experimental | strategy combining respiratory mPCR on a deep respiratory sample obtained by mini bronchoalveolar lavage and algorithm-based therapy developed using local epidemiology Receives: Procedure: strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology |
| Conventional strategy for antibiotic therapy at discretion of ICU physicians | No intervention | The conventional strategy is based on the clinician's choice in accordance with best practice recommendations, without the combined use of respiratory mPCR and algorithm-based therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of a combined use a broad panel respiratory mPCR and an algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for VAP, as compared to a conventional strategy
Proportion of patients receiving optimized antibiotic therapy defined as effective antibiotic therapy and for which antibiotic de-escalation, when recommended, was performed early, within 24 hours after deep respiratory sampling.
Measured: Day 1
Secondary outcomes (11)
Duration of exposure to broad-spectrum antibiotic therapy.
Average number of days of broad-spectrum antibiotic administration per patient at day 28
Measured: Day 28
Compare expected and actual time frames for optimizing antibiotic therapy in the two arms.
Time in hours between deep respiratory sampling and optimization of antibiotic therapy.
Measured: day 28
Quantify early antibiotic de-escalation in the two groups under study
Early and broad-spectrum antibiotic sparing according to the modified Antibiotic Spectrum Index (ASIm) de-escalation score (from No antibiotics (0) to very broad (≥8))
Measured: day 1 and day 7
Rate of Clinical Cure at Day
use test of cure at day 7
Measured: day 7
Mechanical ventilation at day 28
mechanical ventilation free-days at day 28
Measured: day 28
lenght of stay in ICU at day 28
ICU free-days at day 28
Measured: day 28
Number of organ-failure free days (based on SOFA) at day 28
Number of organ-failure free days (based on SOFA) at day 28
Measured: day 28
Mortality at day 28
Mortality at 28
Measured: day 28
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Measured: day 28
Incidence rates of infection or colonization with multidrug resistant bacteria and Clostridium difficile infections at day 28
Incidence rates of infection or colonization with multidrug resistant bacteria and Clostridium difficile infections at day 28
Measured: day 28
Cost of the total hospital admissions
Total Hospitalization Cost per Participant at Day 28 (Including ICU Stay, Antimicrobial Therapy, Microbiological Diagnostic Workup, and Infection Relapse Costs)
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start27 Mar 2026
- Primary completion27 Mar 2028 (estimated)
- Study completion27 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated Pneumonia ( VAP)Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomized, controlled, blinded, parallel-group study evaluates a semi-guided antibiotic strategy based on respiratory mPCR integrated with a locally derived decision algorithm, compared with standard antibiotic care in intensive care patients with ventilator-associated or nosocomial pneumonia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403474
- Sponsor's protocol ID
- 2025-A02343-46
- Acronym
- SMART-VAP
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of a Respiratory Multiplex PCR and Algorithm-based Therapy to Improve Early Optimization of Antibiotic Therapy in Critically Ill Patients With Ventilator-associated Pneumonia : a Bicentric, Parallel-group, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07403474
- Acronym / sponsor ID
- SMART-VAP / 2025-A02343-46
- Conditions
- Ventilator Associated Pneumonia ( VAP)
- Keywords
- mPCR, ventilator associated pneumonia, algorithm-based therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 27 Mar 2028 (estimated)
- Study completion
- 27 Apr 2028 (estimated)
- First posted
- 11 Feb 2026 (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.
Assess the impact of a strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for ventilator-associated pneumonia (VAP) (intervention), compared to a conventional strategy (control).
A bicentric, parallel-group, randomized controlled trial. The primary assessment criterion is the proportion of early optimized antibiotic therapy within 24 hours of respiratory sampling.
Detailed description
In both arms, for eligible patients with VAP, a deep respiratory sample collection is performed prior to inclusion. This collection is carried out either by mini bronchoalveolar lavage (BAL) via bronchoscopy or by blind mini BAL in alignment with the protocolized procedure. Initial antibiotic therapy is initiated after the deep sample has been taken according to the discretion of the attending clinician and in accordance with good practice recommendations. Both groups have their samples analyzed using conventional techniques. First, there is a direct examination, followed by culture and susceptibility testing, which is used as the gold standard technique for evaluating the primary endpoint.
In the intervention arm, in addition to conventional techniques, a broad-panel respiratory mPCR is performed before the 12th hour following achievement of the deep respiratory sample on the collected BAL. Once the mPCR results are received, the clinician adjusts the initial antibiotic therapy using algorithm-based therapy developed using local epidemiology in order to optimize treatment as early as possible.
In the control arm, the strategy is based on the clinician's choice in accordance with best practice recommendations without the combined use of respiratory mPCR and algorithm-based therapy. The deep respiratory sample is analyzed using conventional methods. Initial antibiotic treatment is therefore adapted by the clinician in charge of the patient according to departmental practices based on best practice recommendations, taking into account the results of the direct examination, culture, and susceptibility testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective, randomized, controlled, blinded, parallel-group study evaluates a semi-guided antibiotic strategy based on respiratory mPCR integrated with a locally derived decision algorithm, compared with standard antibiotic care in intensive care patients with ventilator-associated or nosocomial pneumonia.
| Arm | Type | Receives |
|---|---|---|
| combined use of mPCR and algorithm-based therapy | Experimental | Procedure: strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiologystrategy combining respiratory mPCR on a deep respiratory sample obtained by mini bronchoalveolar lavage and algorithm-based therapy developed using local epidemiology |
| Conventional strategy for antibiotic therapy at discretion of ICU physicians | No intervention | –The conventional strategy is based on the clinician's choice in accordance with best practice recommendations, without the combined use of respiratory mPCR and algorithm-based therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adults (≥18 years) with VAP (mechanical ventilation and hospitalization ≥ 48 hours) and deep respiratory sample by mini BAL < 12 hours. The diagnosis of pneumonia includes two clinical criteria among fever (≥38.3°C), purulent sputum or aspiration, hyperleukocytosis (>12,000 WBC/mm³) or leukopenia (<4,000 WBC/mm³), hypoxemia, auscultatory signs in the affected area, and a newly-appeared parenchymal infiltrate
- Patient receiving initial probabilistic antibiotic therapy for VAP suspicion
- Informed consent or emergency procedure
- Patient affiliated with or beneficiary of a health insurance plan.
- Pregnancy
Key exclusion criteria (1 listed)
- mPCR non available
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 |
|---|---|---|
| strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiologystrategy combining respiratory mPCR carried out either by mini bronchoalveolar lavage (BAL) via bronchoscopy or by blind mini BAL, and algorithm-based therapy developed using local epidemiology for the early optimization of initial antibiotic therapy | Procedure or surgery | combined use of mPCR and algorithm-based therapy |
Primary outcome
The effectiveness of a combined use a broad panel respiratory mPCR and an algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for VAP, as compared to a conventional strategy
Time frame: Day 1
Proportion of patients receiving optimized antibiotic therapy defined as effective antibiotic therapy and for which antibiotic de-escalation, when recommended, was performed early, within 24 hours after deep respiratory sampling.
11 secondary outcomes
Duration of exposure to broad-spectrum antibiotic therapy.
Time frame: Day 28
Compare expected and actual time frames for optimizing antibiotic therapy in the two arms.
Time frame: day 28
Quantify early antibiotic de-escalation in the two groups under study
Time frame: day 1 and day 7
Rate of Clinical Cure at Day
Time frame: day 7
Mechanical ventilation at day 28
Time frame: day 28
lenght of stay in ICU at day 28
Time frame: day 28
Number of organ-failure free days (based on SOFA) at day 28
Time frame: day 28
Mortality at day 28
Time frame: day 28
Sensitivity, specificity, and likelihood ratios of the broad panel mPCR Film Array for the diagnosis of pneumonia, taking the conventional microbiological tests as reference
Time frame: day 28
Incidence rates of infection or colonization with multidrug resistant bacteria and Clostridium difficile infections at day 28
Time frame: day 28
Cost of the total hospital admissions
Time frame: day 28
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 13 Oct 2026.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
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Effect of Ventilator Hyperinflation Combined With Body Positioning on ABG in VAP
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology in people with Ventilator Associated Pneumonia ( VAP), run by Centre Hospitalier Universitaire de Nīmes at 2 sites 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 16 inclusion and 1 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hugo MARTINIERE, PH (+33 4 66 68 33 31, hugo.martiniere@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of a combined use a broad panel respiratory mPCR and an algorithm-based therapy developed using local epidemiology on the early optimization of initial antibiotic therapy for VAP, as compared to a conventional strategy (time frame: Day 1). 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 13 Oct 2026.