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

Starting soon · Phase 4

Conditions studied: Ventilator Associated Pneumonia ( VAP)

In brief

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.

Key facts

Study ID

NCT07403474

Run by

Centre Hospitalier Universitaire de Nīmes

People needed

124

Starts

2026-06-01

Expected to finish

2026-07-31

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• mPCR non available

Where it is running

• CHU Nîmes — Nîmes, France

Full record on ClinicalTrials.gov

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