Actively Recruiting
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
41
Research Sites
8 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive either immediate empiric antibiotic therapy started within 1 hour after randomization or a conservative strategy where antibiotics are given only if respiratory sample cultures confirm pneumonia. Antibiotic therapy, if started, is continued for a total of 7 days.
Daily visits or assessments during treatment period
Duration - Up to 28 days
Participants are monitored for clinical outcomes including mechanical ventilation duration, mortality, and occurrence of infections up to 28 days after treatment start.
Regular assessments during hospital stay up to 28 days
Trial Site Locations
Total: 41 locations
1
CHU Angers
Angers, France, France, 49000
Actively Recruiting
2
CH Angoulème
Angoulème, France, France, 16000
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3
CH Argenteuil
Argenteuil, France, France, 95100
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4
CHU Nantes
Nantes, France, France, 44000
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5
CH d'Arles
Arles, France, 13637
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6
CH Avignon
Avignon, France, 84000
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7
Hôpital Nord Franche Comté
Belfort, France, 90000
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8
CHU de Bordeaux
Bordeaux, France, 33076
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9
CHU de Bordeaux
Bordeaux, France
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10
CH Simone Veil
Cannes, France, 06414
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11
CH Public du Cotentin
Cherbourg, France, 50102
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12
CH Cholet
Cholet, France, 49325
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13
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
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14
CH Dax
Dax, France, 40107
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15
CHU Dijon
Dijon, France, 21033
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16
APHP - Hôpital Raymond Poincaré
Garches, France, 92380
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17
CHD Vendée
La Roche-sur-Yon, France, 85025
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18
CH Versailles
Le Chesnay, France, 78157
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19
CH Le Mans
Le Mans, France, 72000
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20
CH Emile Roux
Le Puy-en-Velay, France, 43000
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21
CHRU Lille
Lille, France, 59037
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22
GHB Sud- Hôpital de Lorient
Lorient, France, 56100
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23
CHU de Lyon - Hôpital Edouard Herriot
Lyon, France, 69437
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24
CH de Melun
Melun, France, 77000
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25
CH de Mont de Marsan
Mont-de-Marsan, France, 40000
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26
CHU Nice -Hôpital Pasteur
Nice, France, 06100
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27
CHU Nice - Hôpital de l'Archet
Nice, France, 06200
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28
CHR d'Orléans
Orléans, France, 45100
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29
APHP - Hôpital Cochin
Paris, France, 75014
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30
APHP - Hôpital Tenon
Paris, France, 75020
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31
CH de Pau
Pau, France, 64000
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32
CHU Rennes
Rennes, France, 35033
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33
CH de Saint-Nazaire
Saint-Nazaire, France, 44600
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34
CH de Saint-Malo
St-Malo, France, 35403
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35
CHRU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France, 67091
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36
CHRU de Strasbourg -Hôpital de Hautepierre
Strasbourg, France, 67098
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37
Hôpital Foch
Suresnes, France, 92150
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38
CHRU De Tours
Tours, France, 37044
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39
CH de Valenciennes
Valenciennes, France, 59300
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40
CH Bretagne Atlantique
Vannes, France, 56017
Actively Recruiting
41
CHU La Guadeloupe
Pointe-à-Pitre, Guadeloupe, 97159
Actively Recruiting
Research Team
M
Maëlle MARTIN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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