What is this study trying to find out about ventilator-associated pneumonia?

This study is evaluating when to start antibiotic therapy for suspected non-severe ventilator-associated pneumonia in intensive care patients. Researchers want to compare starting antibiotics immediately versus waiting for lab confirmation to reduce unnecessary antibiotic use and resistance. The goal is to find the best approach to balance risks and benefits for patients under medical care.

Who may be eligible for this ventilator-associated pneumonia clinical trial?

Adults aged 18 years or older who have been on invasive mechanical ventilation for more than 48 hours and have suspected ventilator-associated pneumonia without severe symptoms may be eligible. Both genders can participate. Patients with severe infection signs or certain immune system problems are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this ventilator-associated pneumonia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to receive all necessary medical care related to the study without charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06743529

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

Led by Nantes University Hospital · Updated on 2026-03-27

686

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the timing of antibiotic therapy for patients suspected of having non-severe ventilator-associated pneumonia VAP in intensive care units. This study compares immediate antibiotic treatment started right after respiratory sampling with a conservative approach that waits for microbiological confirmation before beginning treatment. Delaying antibiotics may reduce unnecessary use and antibiotic resistance but might risk worse outcomes if infection is present. The study is a randomized controlled trial led by Nantes University Hospital to better understand these strategies in patients without severe symptoms like septic shock or severe respiratory distress. The trial has two groups the immediate strategy group receives empiric antibiotics within one hour after randomization based on clinical judgment and local protocols. If respiratory samples later test negative, antibiotics are stopped if positive, targeted therapy continues for seven days. The conservative strategy group does not start antibiotics until respiratory sample cultures or PCR results confirm infection. If confirmed, appropriate antibiotics are administered for seven days without waiting for susceptibility testing. Both approaches focus on managing suspected VAP to balance timely treatment and antibiotic stewardship. Participants will be monitored from day 0 to day 28, with assessments including mortality and mechanical ventilation status at day 28 as the main outcome. Additional evaluations cover organ failure scores, lung infection scores, duration of ventilation, use of supportive therapies, hospital and ICU stay lengths, infection incidence, antibiotic use, and cost-utility analysis up to day 90. The study involves informed consent, respiratory sampling within two hours of suspicion, and excludes patients with severe VAP or significant immunosuppression. This comprehensive follow-up aims to clarify the impact of antibiotic timing on patient outcomes and antibiotic resistance in ICU settings.

CONDITIONS

Brief Title

Immediate Versus Substantiated Antibiotic Therapy in Suspected Non-Severe Ventilator-Associated Pneumonia

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Invasive mechanical ventilation for longer than 48 hours
Respiratory sample collected less than two hours ago for a first episode of suspected ventilator-associated pneumonia
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 <4,000/µL, purulent tracheobronchial aspirate
Age 18 years or older
Informed consent from patient or next of kin, or emergency procedure if no next of kin
Affiliated to a social security system

You will not qualify if you...

Severe ventilator-associated pneumonia defined by vasopressor therapy for septic shock or severe hypoxemia (PaO2/FiO2 <150 with 60% FiO2 and 10 mm H2O peak expiratory pressure, or on veno-venous extracorporeal membrane oxygenation)
Immunosuppression with leukocytes <1G/L or neutrophils <0.5 G/L within last 3 months, hematopoietic stem-cell or organ transplant with chronic immunosuppressants, HIV with CD4 <50/mm3, or chronic corticosteroid use >0.5 mg/kg/day for at least one month in last 3 months
Already on antibiotic therapy predicted to last ≥4 weeks
Previous suspicion of ventilator-associated pneumonia with sampling and/or antibiotic therapy
Previous inclusion in this trial
Participation in another interventional study on ventilator-associated pneumonia management with same primary endpoint
Pregnancy, recent delivery, or breastfeeding
Correctional facility inmate, adult under guardianship, or legal protection
Life expectancy less than 48 hours or decision not to treat potential pneumonia under mechanical ventilation
Organ donor reanimation

Research Team

Maëlle MARTIN

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