Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care (the ASPIC trial): study protocol for a randomised controlled trial.
Arnaud Foucrier, Antoine Roquilly, Delphine Bachelet...
https://pubmed.ncbi.nlm.nih.gov/36810173Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05124977
Antimicrobial Stewardship for Ventilator Associated Pneumonia in Intensive Care A Randomized Phase III Clinical Trial Comparing Daily Clinical Assessment Guided Antibiotic Discontinuation Versus Standard 7-Day Therapy
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-25
590
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating antimicrobial stewardship strategies in patients with ventilator-associated pneumonia (VAP) in intensive care units (ICU). VAP is a leading cause of healthcare-associated infections in ICU, often treated with antibiotics, which can contribute to the growing problem of multidrug resistant bacteria worldwide. This study aims to determine if daily clinical assessment to guide antibiotic discontinuation can safely reduce antibiotic use without increasing mortality, treatment failure, or new pneumonia episodes. The study is a prospective, national multicenter, phase III, randomized, single-blinded trial comparing two treatment approaches for confirmed VAP. One group receives antimicrobial stewardship based on daily clinical evaluations to decide when to stop antibiotics if signs of clinical cure are met. The control group follows standard management with a mandatory minimum 7-day antibiotic course regardless of clinical improvement. Intensivists assess patients daily in both groups to guide treatment duration. Participants will undergo daily clinical assessments of signs like tracheal secretion regression, temperature normalization, and oxygenation improvement. Researchers will monitor outcomes such as all-cause mortality, treatment failure, new pneumonia episodes, antibiotic-free days, duration of mechanical ventilation, ICU stay length, and antibiotic-related complications over 28 days. The study includes informed consent procedures and aims to assess safety and effectiveness of shorter antibiotic courses in ICU patients with VAP.
CONDITIONS
Brief Title
Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of microbiologically confirmed first episode of ventilator-associated pneumonia
- Initial appropriate antibiotic therapy started
- Written informed consent from patient or legal representative, or emergency inclusion if no representative
- Patient on mechanical ventilation for more than 48 hours at time of microbiological sampling
- New pulmonary infiltrate suspected to be infectious
- Worsening oxygenation
- Clinical signs within 24 hours before first antibiotic dose: purulent tracheal secretions plus at least one of: fever above 38.3°C, hypothermia below 35°C, or abnormal white blood cell count
- Positive quantitative culture from lower respiratory tract samples meeting specified thresholds
You will not qualify if you...
- Patient receiving selective decontamination of digestive tract
- Antibiotic therapy duration over 72 hours before inclusion appropriate to bacteria found
- Participation in another interventional antimicrobial study
- Moribund condition with IGS II over 80
- Thoracic trauma with Abbreviated Injury Scale of 3 or more
- Severe immunocompromise such as congenital immunodeficiency, neutropenia, hematologic malignancy, stem cell transplant, or HIV with low CD4 count
- Receiving immunosuppressive therapy or long-term corticosteroids above 0.5 mg/kg
- VAP caused by Pseudomonas aeruginosa, carbapenem-resistant Acinetobacter spp, or carbapenem-resistant Enterobacteriaceae
- VAP with COVID-19 or other viral pneumonia confirmed by PCR
- Empyema, necrotizing, or abscessed pneumonia
- Need for extracorporeal oxygen therapy (ECMO)
- Pregnancy
- No health insurance coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 7 days or until clinical cure is achieved
Participants receive antibiotic therapy for ventilator-associated pneumonia. In the experimental group, antibiotic therapy is guided by daily clinical assessment and may be discontinued early if clinical cure is achieved. In the control group, antibiotic therapy is given for a fixed duration of 7 days regardless of clinical improvement.
Daily clinical assessments during treatment
Follow-up
Duration - 28 days after treatment starts
Participants are monitored for outcomes including mortality, treatment failure, and occurrence of new pneumonia episodes up to 28 days after treatment initiation.
Periodic assessments up to 28 days
Trial Site Locations
Total: 1 location
1
Foucrier
Clichy-sous-Bois, France
Actively Recruiting
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Research Team
A
Arnaud Foucrier
E
Emmanuel Weiss
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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