Actively Recruiting
Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
Led by Nantes University Hospital · Updated on 2025-08-11
450
Participants Needed
26
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.
CONDITIONS
Official Title
Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospital-acquired pneumonia diagnosed by European guidelines with at least two criteria among fever over 38°C, high or low white blood cell count, purulent lung secretions, new or changed chest X-ray infiltrate, and respiratory sample collected for bacterial diagnosis
- Pneumonia severity with PaO2/FiO2 ratio below 300 while on mechanical ventilation
- Biological systemic inflammation with CPR ≥ 150 mg/L
- Receiving antimicrobial treatment for the current pneumonia episode for less than 48 hours
- Informed consent obtained from legal representative or emergency procedure consent as allowed
- Covered by a health insurance plan
- Women of childbearing age agree to and can use effective contraception for the first 28 days of the study
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients under legal protection such as guardianship or trusteeship
- Known allergy to dexamethasone or its components
- Receiving glucocorticoids at randomization, including for COVID-19 needing oxygen
- Severe septic shock requiring high-dose norepinephrine and elevated serum lactate at randomization
- Long-term corticosteroid use at prednisone equivalent ≥ 0.3 mg/kg/day for over 3 weeks in past 60 days
- Uncontrolled viral or systemic fungal infections
- Immunosuppression before hospitalization, including severe lymphopenia or recent cancer treatments
- Uncontrolled psychotic disorders
- Patients not expected to survive beyond 48 hours
- Participation in other drug trials affecting steroids, chemotherapy, or with known drug interactions or impacting follow-up or safety
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Chu Amiens
Amiens, France
Actively Recruiting
2
CHU Angers
Angers, France
Actively Recruiting
3
Chu Bordeaux
Bordeaux, France
Actively Recruiting
4
Chu Bordeaux
Bordeaux, France
Not Yet Recruiting
5
CHU Brest
Brest, France
Actively Recruiting
6
CHU Caen
Caen, France
Actively Recruiting
7
CHU Clermont - Ferrand
Clermont-Ferrand, France
Actively Recruiting
8
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
9
CHU Clermont-Ferrand
Clermont-Ferrand, France
Actively Recruiting
10
CHU Beaujon
Clichy, France
Actively Recruiting
11
CHU Raymond Poincaré
Garches, France
Actively Recruiting
12
Chu Grenoble
Grenoble, France
Actively Recruiting
13
CHU Limoges
Limoges, France
Actively Recruiting
14
CHU Marseille
Marseille, France
Actively Recruiting
15
Chu Nancy
Nancy, France
Actively Recruiting
16
CHU Nantes (HGRL)
Nantes, France, 44000
Actively Recruiting
17
CHU Nantes
Nantes, France, 44000
Actively Recruiting
18
CHU Nantes (HGRL)
Nantes, France
Actively Recruiting
19
Chu Nimes
Nîmes, France
Actively Recruiting
20
CHU Pitié Salpétrière
Paris, France
Actively Recruiting
21
CHU Pitié Salpétrière
Paris, France
Actively Recruiting
22
CHU Poitiers
Poitiers, France
Actively Recruiting
23
CHU Rennes
Rennes, France
Actively Recruiting
24
CHU Rennes
Rennes, France
Actively Recruiting
25
Chu Strasbourg
Strasbourg, France
Actively Recruiting
26
Chu Toulouse
Toulouse, France
Not Yet Recruiting
Research Team
A
Antoine ROQUILLY
CONTACT
L
Lucile MARGUET
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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