NCT00973154

Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Prednisone	50mg per day of prednisone orally for 7 days versus placebo

Timeline

• Start date: 2009-12-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2009-09-09
• Last updated: 2015-04-21

Locations

7 sites across 1 country: Switzerland