Community-acquired Pneumonia Clinical Trial
Official title:
Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial
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
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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