Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

Study Overview
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Brief Summary
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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

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

Conditions
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Community-acquired Pneumonia

Intervention / Treatment
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* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP. CAP will be defined by a new infiltrate on chest radiograph and the presence of one or several of the following acute respiratory signs or symptoms: cough sputum production dyspnea core body temperature >38.0° C auscultatory findings of abnormal breath sounds and rales leukocyte count >10 or <4 x 109 cells L-1 (1) Exclusion Criteria: Patients or family members unable to give written informed consent, e.g. with severe dementia. Patients with active intravenous drug use. Severe immunosuppression (e.g. patients infected with human immunodeficiency virus infection and a CD4 count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count < 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values < 500 x 109/L); patients with cystic fibrosis as well as patients with active tuberculosis. Patients with acute burn injury Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent Pregnancy or breast feeding Patients with known adrenal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisone<br>Drug | Drug: Prednisone<br>* 50mg per day of prednisone orally for 7 days versus placebo<br>|
| Placebo Comparator: Placebo<br> | Drug: Prednisone<br>* 50mg per day of prednisone orally for 7 days versus placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clinical stability |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of corticosteroids, mortality, recurrence |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Corticosteroids, clinical stability