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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Angers
  Angers, France, France Recruiting
• CH Angoulème
  Angoulème, France, France Recruiting
• CH Argenteuil
  Argenteuil, France, France Recruiting
• CHU Nantes
  Nantes, France, France Recruiting
• CH d'Arles
  Arles, France Recruiting
• CH Avignon
  Avignon, France Recruiting

Study contacts

• Study coordinator: Maëlle MARTIN
• Email: maelle.martin@chu-nantes.fr
• Phone: 0240 087 365

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Innate Immune Immunoparalysis and Ventilator-Associated Pneumonia in Critically Ill Elderly Patients

  This study tests whether signs of innate immune immunoparalysis in adults on ventilators are linked to developing ventilator-associated pneumonia (VAP).

  Recruiting Hospital Universitari de Bellvitge · L'Hospitalet de Llobregat, Barcelona · NCT07551258

• Combined mPCR and algorithm-based therapy to optimize early antibiotics in VAP

  This trial tests whether adding a broad respiratory mPCR test and a local-epidemiology algorithm helps doctors choose better initial antibiotics within 24 hours for adults with ventilator-associated pneumonia.

  Recruiting at 2 sites Phase 4 Centre Hospitalier Universitaire de Nīmes · Alès and 1 other locations · NCT07403474

• Using airway resistance changes to guide suctioning for ventilated patients

  This study will test whether monitoring airway viscous resistance from ventilator waveforms can help time sputum suctioning for patients on mechanical ventilation with ARDS, AECOPD, or severe pneumonia.

  Recruiting at 3 sites Affiliated Hospital of Nantong University · Bengbu, Anhui and 2 other locations · NCT07375667

• Two Oral Care Methods for Mechanically Ventilated Adults

  This trial tests whether a pediatric toothbrush or a foam swab for oral care affects oral bacteria and the risk of ventilator-associated pneumonia in adults on mechanical ventilation.

  Recruiting Marmara University · Zonguldak · NCT07283380

• Aztreonam‑avibactam for MBL-producing CRE infections in hospitalized adults

  This study will see if aztreonam‑avibactam helps hospitalized adults with complicated intra‑abdominal infections or hospital/ventilator‑associated pneumonia caused by MBL-producing CRE.

  Recruiting Sir Run Run Shaw Hospital · Nanchang, Jiangxi and 1 other locations · NCT07268560

• Early detection of ventilator-associated pneumonia in critically ill children using microbial and immune signatures.

  This project will test whether combining microbial genomic data and a child's immune-response signals can detect ventilator-associated pneumonia earlier in critically ill children on mechanical ventilation.

  Recruiting University of Cambridge · Cambridge · NCT07026656

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.