Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Basel, Switzerland
Sponsor:
Collaborators:
Kantonsspital Aarau
Kantonsspital Liestal
Information provided by (Responsible Party):
Mirjam Christ-Crain, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00973154
First received: September 7, 2009
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects of corticosteroids, mortality, recurrence [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973154

Contacts
Contact: Mirjam Christ-Crain, MD +41 61 265 5078 mirjam.christ-crain@unibas.ch

Locations
Switzerland
Medizinische Klinik, Kantonsspital Liestal Recruiting
Liestal, BL, Switzerland, 4410
Contact: Werner Zimmerli, MD    +41 61 925 25 25      
Contact: Elke Ullmer, MD    +41 61 925 25 25      
Principal Investigator: Werner Zimmerli, MD         
Medicine Interne, Hôpital du Jura, site de Delémont Recruiting
Delémont, JU, Switzerland, 2800
Contact: Hervé Duplain, MD, PhD    +41 32 421 21 21      
Principal Investigator: Hervé Duplain, MD, PhD         
Kantonsspital Aarau Recruiting
Aarau, Switzerland
Contact: Beat Mueller, Prof    +41 838 6818    happy.mueller@unibas.ch   
Principal Investigator: Beat Mueller, MD         
University Hospital Basel Recruiting
Basel, Switzerland, 4052
Contact: Mirjam Christ-Crain, MD       mirjam.christ-crain@unibas.ch   
Principal Investigator: Mirjam Christ-Crain, MD         
Inselspital Recruiting
Bern, Switzerland
Contact: Nicolas Rodondi, MD       nicolas.rodondi@insel.ch   
Principal Investigator: Nicolas Rodondi, MD         
Bruderholzspital Recruiting
Bruderholz, Switzerland
Contact: Philip Tarr, MD       philip.tarr@ksbh.ch   
Principal Investigator: Philip Tarr, MD         
Bürgerspital Recruiting
Solothurn, Switzerland
Contact: Robert Thomann, MD       procalcitonin@bluewin.ch   
Principal Investigator: Robert Thomann, MD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Kantonsspital Aarau
Kantonsspital Liestal
Investigators
Principal Investigator: Mirjam Christ-Crain, MD University Hospital, Basel, Switzerland
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional 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
Study First Received: September 7, 2009
Last Updated: May 19, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 19, 2014