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Immediate versus confirmed-start antibiotics for suspected non-severe ventilator-associated pneumonia

Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia: A Randomized Controlled Trial

Not applicable Interventional Nantes University Hospital · NCT06743529

This study will try starting antibiotics right away versus waiting for lab confirmation in adults on a ventilator who have a first suspected non-severe VAP.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment686 (estimated)
Ages18 Years and up
SexAll
SponsorNantes University Hospital Academic / other
Locations41 sites (Angers, France and 40 other locations)
Trial IDNCT06743529 on ClinicalTrials.gov

What this trial studies

This interventional multicenter French study compares two antibiotic strategies for adults mechanically ventilated >48 hours with a first episode of suspected non-severe ventilator-associated pneumonia. After respiratory sampling, participants are assigned to either immediate antibiotic therapy or a conservative approach where antibiotics are started only if bacteriology confirms infection, with patients in shock or with very severe hypoxemia excluded. The trial monitors antibiotic exposure, clinical outcomes such as duration of mechanical ventilation and complications, and the development of resistant bacteria. Recruitment takes place at Nantes University Hospital and collaborating regional hospitals in Angers, Angoulême, and Argenteuil.

Who should consider this trial

Good fit: Adults (≥18) who have been on invasive mechanical ventilation for more than 48 hours, have a first suspected non-severe VAP with respiratory sampling taken within about two hours, and can provide consent (or have proxy consent) are eligible.

Not a fit: Patients with severe VAP (on vasopressors for septic shock or with marked hypoxemia such as PaO2/FiO2 <150), or those needing immediate antibiotics for other clear infections, are not expected to benefit from the conservative approach and are excluded.

Why it matters

Potential benefit: If successful, the approach could safely reduce unnecessary antibiotic use and lower the risk of selecting resistant bacteria while preserving patient outcomes.

How similar studies have performed: Observational data show only 30–50% of suspected VAP cases are bacteriologically confirmed and antibiotic-sparing approaches have been proposed, but randomized evidence directly comparing immediate versus confirmed-start strategies is limited.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Angers, France and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ventilator-Associated PneumoniaIntensive care medicineIntensive careVentilator-associated pneumoniaantibiotic sparing
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.