patients with acute respiratory failure from undetermined etiology
Conditions
Brief summary
Mortality at day 90
Detailed description
ICU mortality, hospital mortality, day 28 mortality, proportion of patients with ICU acquired microbiologically documented bacterial infections, proportion of patients with invasive fungal infection within 3 months following randomization, roportion of patients with HSV, VZV or CMV reactivation within 3 months following randomization, occurrence of severe hypokalemia (<2,5 meq/l), decompensated diabetes or severe or newly acquired hypertension, emergence of Aspergillus species with decreased sensitivity to isavuconazole, Incidence of Candida infection, incidence of post-traumatic Stress Disorder (IES-R), anxiety and depression at 6 months (HADS), quality of life at 6 months (SF36)
Interventions
DRUGMETHYLPREDNISOLONE
DRUGPlacebo of CRESEMBA
DRUGCRESEMBA 200 mg powder for concentrate for solution for infusion
DRUGPlacebo of methylprednisolone
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality at day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU mortality, hospital mortality, day 28 mortality, proportion of patients with ICU acquired microbiologically documented bacterial infections, proportion of patients with invasive fungal infection within 3 months following randomization, roportion of patients with HSV, VZV or CMV reactivation within 3 months following randomization, occurrence of severe hypokalemia (<2,5 meq/l), decompensated diabetes or severe or newly acquired hypertension, emergence of Aspergillus species with decreased sensitivity to isavuconazole, Incidence of Candida infection, incidence of post-traumatic Stress Disorder (IES-R), anxiety and depression at 6 months (HADS), quality of life at 6 months (SF36) | — |
Countries
France
Outcome results
None listed