About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
mPCR non available
Trial design
Parallel
Treatments tested in this trial
strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology
Procedure/Surgerystrategy 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Duration of exposure to broad-spectrum antibiotic therapy.
Average number of days of broad-spectrum antibiotic administration per patient at 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.
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))
Rate of Clinical Cure at Day
use test of cure at day 7
Sponsors and contacts
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