A Phase 4 interventional study of strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology in Ventilator Associated Pneumonia ( VAP), sponsored by Centre Hospitalier Universitaire de Nīmes. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Phase 4, Interventional, and Treatment
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.
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.
392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.
This study's planned enrollment of 124 is close to the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.
Browse Pneumonia, Ventilator-Associated studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
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Non inclusion Criteria:
Exclusion criteria :
strategy combining respiratory mPCR on a deep respiratory sample obtained by mini bronchoalveolar lavage and algorithm-based therapy developed using local epidemiology
Procedure: strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology
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.
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
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.
Time frame: Day 1
Duration of exposure to broad-spectrum antibiotic therapy.
Average number of days of broad-spectrum antibiotic administration per patient at day 28
Time frame: 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.
Time frame: 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))
Time frame: day 1 and day 7
Rate of Clinical Cure at Day
use test of cure at day 7
Time frame: day 7
Mechanical ventilation at day 28
mechanical ventilation free-days at day 28
Time frame: day 28
lenght of stay in ICU at day 28
ICU free-days at day 28
Time frame: 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
Time frame: day 28
Mortality at day 28
Mortality at 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
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
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
Total Hospitalization Cost per Participant at Day 28 (Including ICU Stay, Antimicrobial Therapy, Microbiological Diagnostic Workup, and Infection Relapse Costs)
Time frame: day 28
Plan to share: No
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Pneumonia, Ventilator-Associated→
Centre Hospitalier Universitaire de Nīmes