Ignite Creation Date:
2024-05-05 @ 9:51 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00973154
Status:
COMPLETED
Last Update Posted:
2015-04-21
First Post:
2009-09-07
Brief Title:
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized Double-blind Study- The STEP Trial
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None