Status:

RECRUITING

Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia

Lead Sponsor:

Nantes University Hospital

Conditions:

Ventilator-Associated Pneumonia (VAP)

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Ventilator-associated pneumonia is the leading nosocomial infection in the intensive care units, and is associated with prolonged mechanical ventilation and overuse of antibiotics. Initiating antibiot...

Eligibility Criteria

Inclusion Criteria:

  • Invasive mechanical ventilation for longer than 48 hours

  • Respiratory sample collection taken less than two hours ago (at physician discretion, according to local protocol) for a first episode of suspected ventilator-associated pneumonia (meeting the following prespecified criteria) :

    • new or changing chest X-ray infiltrates

    • plus at least two of the following:

      • body temperature ≥38.3°C or ≤35.5°C,
      • blood leukocyte count >12 000/µL or <4000/µL,
      • purulent tracheobronchial aspirate.
  • Age ≥18 years

  • Informed consent from the patient or next of kin to participation in the trial, or emergency procedure if no next of kin is available

  • Patients affiliated to a social security system

Non-inclusion Criteria:

  • Criteria for severe ventilator-associated pneumonia defined as:

    • Vasopressor therapy for onset of septic shock around the time of ventilator-associated pneumonia suspicion
    • Onset or severe worsening of hypoxemia (PaO2/FiO2<150 with 60% FiO2 and 10 mm H2O peak expiratory pressure, or patient on veno-venous extracorporeal membrane oxygenation)
  • Immunosuppression defined as :

    • leukocytes <1G/L or neutrophils <0,5 G/L
    • within the last 3 months
    • hematopoietic stem-cell transplant or organ transplant with chronic immunosuppressant therapy
    • HIV infection with CD4<50/mm3
    • chronic corticosteroid use (>0.5 mg/kg day for at least one month within the last three months).
  • Patient already on Antibiotic Therapy of predicted duration ≥4 weeks (endocarditis, spondylodiscitis, abscess...)

  • Previous ventilator-associated pneumonia suspicion with sampling and/or Antibiotic Therapy for suspected ventilator-associated pneumonia

  • Previous inclusion in the trial

  • Patient included in an interventional study on ventilator-associated pneumonia management with the same primary endpoint.

  • Pregnancy, recent delivery, or breastfeeding

  • Correctional facility inmate, adult under guardianship

  • Patient under legal protection

  • Life expectancy less than 48 h and/or decision not to treat potential pneumonia acquired under mechanical ventilation in the context of limiting/discontinuing treatment.

  • Organ donor reanimation

Key Trial Info

Start Date :

November 11 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 11 2029

Estimated Enrollment :

686 Patients enrolled

Trial Details

Trial ID

NCT06743529

Start Date

November 11 2025

End Date

February 11 2029

Last Update

March 27 2026

Active Locations (41)

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Page 1 of 11 (41 locations)

1

CHU Angers

Angers, France, France, 49000

2

CH Angoulème

Angoulème, France, France, 16000

3

CH Argenteuil

Argenteuil, France, France, 95100

4

CHU Nantes

Nantes, France, France, 44000