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Compares treatment options for Ventilator-Associated Pneumonia (VAP)
Official title Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia
ClinicalTrials.gov ID: NCT06743529
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- new or changing chest X-ray infiltrates
- plus at least two of the following:
- body temperature ≥38.3°C or ≤35.5°C,
See the full eligibility 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...
- 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-
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France, France
- Angoulème, France, France
- Argenteuil, France, France
- Nantes, France, France
- Arles, France
- Avignon, France
- Belfort, France
- Bordeaux, France
- Cannes, France
- Cherbourg, France
- Cholet, France
- Clermont-Ferrand, France
- Dax, France
- Dijon, France
- Garches, France
- La Roche-sur-Yon, France
- Le Chesnay, France
- Le Mans, France
- Le Puy-en-Velay, France
- Lille, France
+ 17 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France, France; Angoulème, France, France; Argenteuil, France, France; Nantes, France, France; Arles, France; Avignon, France and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.