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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
450
Dexamethasone phosphate injection is given as a slow injection or infusion (intravenous drip) into the veins.
Placebo 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).
Time frame: Day 8-10
The rate of all-cause mortality on Day 28.
Time frame: Day 28
Rate of death
All-cause mortality
Time frame: Month 3 , Month 6
Rate of pleural empyema at Day 28.
Time frame: Day 28
Rate of microbiological failure
Time frame: Toc 1 day visit
Rate of pneumonia relapse
Time frame: day 28
Duration of hospitalization and hospital-free days
Time frame: Month 6
Rates of non-respiratory hospital-acquired infection
Time frame: Day 28
Antibiotic-free days at Day 28
Time frame: Day 28
Duration of invasive mechanical ventilation and invasive mechanical ventilation-free days
Time frame: Month 6
Rate of SUSAR ( suspected unexpected serious adverse reaction) and AE ( Adverse event)
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Chu Amiens
Amiens, France
ACTIVE_NOT_RECRUITINGCHU Angers
Angers, France
RECRUITINGChu Bordeaux
Bordeaux, France
RECRUITINGChu Bordeaux
Bordeaux, France
RECRUITINGCHU Brest
Brest, France
RECRUITINGCHU Caen
Caen, France
ACTIVE_NOT_RECRUITINGCHU Clermont - Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGCHU Beaujon
Clichy, France
ACTIVE_NOT_RECRUITING...and 24 more locations
* Rate of serious adverse reactions and suspected unexpected serious adverse reaction (SUSAR) * Rate of metabolic adverse events
Time frame: day 28
Rate of gastric ulcer
Time frame: day 28
Anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale
Changes in anxiety and depression were measured with the HADS (Hospital Anxiety and Depression Scale ) scale in order to assess the acceptability of dexamethasone from the patients' perspectives
Time frame: month 3, month 6
Changes in subjective well-being with the Satisfaction With Life Scale (SWLS)
Changes in subjective well-being from M3 to M6 measured with the Satisfaction With Life Scale (SWLS) in order to assess the acceptability of dexamethasone from the patients' perspectives
Time frame: month 3, month 6
Changes in health-related quality of life measured with the Short Form (SF)-36
Changes in health-related quality of life with the Short Form (SF)-36 scale in order to assess the acceptability of dexamethasone from the patients' perspectives:
Time frame: month 3, month 6
the cost-effectiveness analysis (CEA ) will estimate an incremental cost-effectiveness ratio (ICER)
We will assess the economic efficiency of dexamethasone plus standard of care compared to standard of care by performing a cost-effectiveness analysis (CEA) using QALYs (Quality-Adjusted Life-Years) as a measure of health outcomes. the CEA will estimate an incremental cost effectiveness ratio (ICER) using a collective perspective; The ICER will be expressed in terms of costs per QALY gained.
Time frame: month 6