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.
Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body temperature > 38°C, leukocytosis>12000 cells per mL, leucopenia <4000 cells per mL and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, AET, BAL, mini-BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU. Diagnosis is done at least 48 hours after hospital admission.
HAP severity defined as a PaO2/FiO2 ratio < 300 under mechanical ventilation.
Biological systemic inflammatory response defined as CPR≥ 150 mg/L (15 mg/dL)*
Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours.
Pregnant women (serum or urine test), breastfeeding women.
Patient under legal protection (incl. under guardianship or trusteeship).
Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients
Ongoing administration of glucocorticoid at the time of randomisation, such as for COVID-19 infection requiring supplemental oxygen therapy
Parallel
Dexamethasone
DrugDexamethasone phosphate injection is given as a slow injection or infusion (intravenous drip) into the veins.
Placebo
DrugPlacebo injection is given as a slow injection or infusion (intravenous drip) into the veins.
Clinical cure rate at the test-of-cure visit (TOC visit)
It's a hierarchic procedure. First, we will test the dexamethasone superiority on the clinical cure rate at the test-of-cure visit realized 8 days (acceptable time frame Day 8-10) after randomization or at the ICU discharge (if it occurs before).
The rate of all-cause mortality on Day 28.
Rate of death
All-cause mortality
Rate of pleural empyema at Day 28.
Rate of microbiological failure
Rate of pneumonia relapse
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