RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Centre Hospitalier Universitaire de Nīmes • ClinicalTrials.gov ID: NCT07403474

Registry updated: 2026-10-13

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Description

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.

Interventions

strategy combining respiratory mPCR and algorithm-based therapy developed using local epidemiology (Procedure)
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

Eligibility criteria

Inclusion Criteria: * 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 * 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. Exclusion criteria : * mPCR non available

Conditions

Ventilator Associated Pneumonia ( VAP)

Locations

CH ALES — Alès, France
CHU Nîmes — Nîmes, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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