Actively Recruiting
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-25
590
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Increasing emergence of multidrug resistant (MDR) bacteria worldwide is now considered one of the most urgent threats to global health. The association between increase of antibiotics consumption and resistance emergence has been well documented for all patients admitted to the Intensive care unit (ICU) who received antibiotic treatment and for patients treated for ventilator associated pneumonia (VAP). Reduction of use of antibiotics is a major point in the war against antimicrobial resistance. VAP is the first cause of healthcare-associated infections in ICU and more than half of antibiotics prescriptions in ICU are due to VAP. Once the diagnosis of pneumonia under MV has been made, initiation of antibiotic treatment must be prompt but there is no clear consensus on its duration. In the case of a good clinical response to treatment, it has been shown in some situations that short course antibiotics can be effective without side effects and antimicrobial stewardship initiatives can be applied successfully and effectively to the management of Community Acquired Pneumonia (CAP). The hypothesis is that an antimicrobial stewardship is possible in the treatment of VAP with no increase in the rate of all-cause mortality, treatment failure or occurrence of new episode of pneumonia. The objective is to investigate whether an antimicrobial stewardship for VAP based on daily assessment of clinical cure and antimicrobial discontinuation, if it is obtained, would be non-inferior in terms of all-cause mortality, treatment failure or occurrence of new episode of pneumonia. This study will be a prospective, national multicenter (31 centers), phase III, comparative randomized (1:1), single-blinded clinical trial comparing two management strategies of treatment of pneumonia on the basis of two parallel arms: Experimental group: Antimicrobial stewardship based on daily clinical assessment of clinical cure. Control group: standard management: duration of appropriate antibiotic therapy for confirmed VAP according to guidelines.
CONDITIONS
Official Title
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of microbiologically confirmed first episode of ventilator associated pneumonia (VAP)
- Initial appropriate antibiotic therapy given (empirical or not)
- Written informed consent from patient or legal representative, or emergency inclusion if no representative
- Patient under mechanical ventilation for more than 48 hours at microbiological sampling
- New pulmonary infiltrate strongly suspected to be infectious
- Worsening oxygenation
- Presence of purulent tracheal secretions within 24 hours before first antibiotic dose
- At least one of: documented fever (>38.3°C) or hypothermia (<35°C) or abnormal white blood cell count (>10,000 or <4,000 cells/mm3)
- Positive quantitative culture from lower respiratory tract samples meeting specified colony-forming units thresholds
You will not qualify if you...
- Patient undergoing selective decontamination of digestive tract
- Antibiotic therapy duration over 72 hours before inclusion appropriate to identified bacteria
- Participation in another antimicrobial strategy interventional study
- Moribund condition (IGS II >80)
- Severe thoracic trauma with Abbreviated Injury Scale (AIS) thorax ≥3
- Severe immunocompromise (congenital immunodeficiency, neutropenia, acute hematologic malignancy, stem cell transplant, HIV with CD4 <200/mm3)
- Receiving immunosuppressive therapy or long-term corticosteroids >0.5 mg/kg
- VAP caused by Pseudomonas aeruginosa, Carbapenem-resistant Acinetobacter spp, or Carbapenem-resistant Enterobacteriaceae
- VAP with co-infection of COVID-19 or other viral pneumonia confirmed by RT-PCR
- Presence of empyema, necrotizing, or abscessed pneumonia
- Requirement for extracorporeal oxygen therapy (ECMO)
- Pregnant women
- Lack of health insurance coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Foucrier
Clichy-sous-Bois, France
Actively Recruiting
Research Team
A
Arnaud Foucrier
CONTACT
E
Emmanuel Weiss
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here