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Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial (STEP)

This study has been completed.
Kantonsspital Aarau
Kantonsspital Liestal
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland Identifier:
First received: September 7, 2009
Last updated: April 20, 2015
Last verified: May 2014

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

Condition Intervention Phase
Community-acquired Pneumonia
Drug: Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial

Resource links provided by NLM:

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Time to clinical stability [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Side effects of corticosteroids, mortality, recurrence [ Time Frame: 30 days ]

Enrollment: 800
Study Start Date: December 2009
Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisone
Drug: Prednisone
50mg per day of prednisone orally for 7 days versus placebo
Placebo Comparator: Placebo Drug: Prednisone
50mg per day of prednisone orally for 7 days versus placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients 18 years of age or older admitted for hospitalization from the community or a nursing home with CAP.
  2. 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:

  1. Patients or family members unable to give written informed consent, e.g. with severe dementia.
  2. Patients with active intravenous drug use.
  3. 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.
  4. Patients with acute burn injury
  5. Patients with acute gastrointestinal bleeding within 3 months of the current hospitalization
  6. Patients with an acute concomitant condition requiring more than 0.5mg/kg/d prednisone equivalent
  7. Pregnancy or breast feeding
  8. Patients with known adrenal insufficiency
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Please refer to this study by its identifier: NCT00973154

Medizinische Klinik, Kantonsspital Liestal
Liestal, BL, Switzerland, 4410
Medicine Interne, Hôpital du Jura, site de Delémont
Delémont, JU, Switzerland, 2800
Kantonsspital Aarau
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Bern, Switzerland
Bruderholz, Switzerland
Solothurn, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Kantonsspital Liestal
Principal Investigator: Mirjam Christ-Crain, MD University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mirjam Christ-Crain, Prof. Dr. med. Leitende Aerztin, University Hospital, Basel, Switzerland Identifier: NCT00973154     History of Changes
Other Study ID Numbers: STEP
Study First Received: September 7, 2009
Last Updated: April 20, 2015

Keywords provided by University Hospital, Basel, Switzerland:
clinical stability

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on April 26, 2017