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

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ClinicalTrials.gov Identifier: NCT00973154
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : April 21, 2015
Sponsor:
Collaborators:
Kantonsspital Aarau
Kantonsspital Liestal
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland

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


Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : December 2009
Primary Completion Date : July 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Steroids
Drug Information available for: Prednisone
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Prednisone
Drug
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



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

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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973154


Locations
Switzerland
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
Inselspital
Bern, Switzerland
Bruderholzspital
Bruderholz, Switzerland
Bürgerspital
Solothurn, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Kantonsspital Liestal
Investigators
Principal Investigator: Mirjam Christ-Crain, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mirjam Christ-Crain, Prof. Dr. med. Leitende Aerztin, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00973154     History of Changes
Other Study ID Numbers: STEP
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: May 2014

Keywords provided by Mirjam Christ-Crain, University Hospital, Basel, Switzerland:
Pneumonia
Corticosteroids
clinical stability

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents