Community-Acquired Pneumonia : Evaluation of Corticosteroids
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Mortality of severe Community-Acquired Pneumonia (CAP) has not declined over time and is
between 25 and 30% in sub-groups of patients. Corticosteroids (CTx) could down-regulate
pulmonary and systemic inflammation, accelerate clinical resolution and decrease the rate of
inflammation-associated systemic complications. Two recent meta-analyses suggest a positive
effect on severe CAP day 28 survival when CTx are added to standard therapy. However they are
based on only four trials gathering less than 300 patients, of which only one was positive.
Recently published guidelines do not recommend CTx as part of CAP treatment. Therefore a
well-powered trial appears necessary to test the hypothesis that CTx - and more specifically
hydrocortisone - could improve day 28 survival of critically-ill patients with severe CAP,
severity being assessed either on a Pulmonary Severity Index ≥ 130 (Fine class V) or by the
use of mechanical ventilation or high-FiO2 high-flow oxygen therapy.
A phase-III multicenter add-on randomized controlled double-blind superiority trial assessing
the efficacy of hydrocortisone vs. placebo on Day 28 all-causes mortality, in addition to
antibiotics and supportive care, including the correction of hypoxemia.
Randomization will be stratified on: (i) centers; (ii) use of mechanical ventilation at the
time of inclusion.