Overview

Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Background: An intact hypothalami-pituitary-adrenal (HPA) axis with an effective intracellular anti-inflammatory activity of glucocorticoids is indispensable for host survival during stress upon exposure to an infectious agent. Community-acquired pneumonia (CAP) is characterized by significant mortality and increased circulating inflammatory cytokines. Despite adequate antimicrobial therapy mortality rates for CAP have not changed over several decades. The use of corticosteroids in patients with CAP is inconclusive. Study aim: To compare a 7 days treatment with prednisone and placebo in patients with community-acquired pneumonia with respect to time to clinical stability. Study hypothesis: The investigators hypothesize that use of corticosteroids will lead to a 25% relative risk reduction for death and clinical instability. Study type: randomized double blind intervention study Patients: 800 patients with community-acquired pneumonia
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborators:
Kantonsspital Aarau
Kantonsspital Liestal
Treatments:
Prednisone