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
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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).
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Patient already on Antibiotic Therapy of predicted duration ≥4 weeks (endocarditis, spondylodiscitis, abscess...)
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Previous ventilator-associated pneumonia suspicion with sampling and/or Antibiotic Therapy for suspected ventilator-associated pneumonia
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Previous inclusion in the trial
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Patient included in an interventional study on ventilator-associated pneumonia management with the same primary endpoint.
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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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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