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

RecruitingNAAges 18 Years - anyAllNantes University Hospital
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In plain words

What the trial is, and whether it could suit you

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 antibiotic therapy immediately after bacteriological sampling (immediate strategy) may expose uninfected patients to unnecessary treatment, while waiting for bacteriological confirmation (conservative strategy) may delay ventilator-associated pneumonia in infected patients. The decision to start antibiotic therapy for ventilator-associated pneumonia takes three points into account: diagnostic probability, the risks to the patient if Antibiotic Therapy is delayed, and the risk of selection of resistant bacteria. Diagnostic probability is limited, given the subjective and non-specific nature of the diagnostic criteria, and only 30-50% of suspected cases are confirmed bacteriologically (whereas sample

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📋 Eligibility rules (as published)
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°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
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What it tests

  • control group
  • Conservative strategy
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Where

42 sites
CHU Angers
Angers, France
CH Angoulème
Angoulème, France
CH Argenteuil
Argenteuil, France
CHU Nantes
Nantes, France
CH d'Arles
Arles, France
CH Avignon
Avignon, France
Hôpital Nord Franche Comté
Belfort, France
CHU de Bordeaux
Bordeaux, France

…and 34 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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