Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial
This study is currently recruiting participants.
Verified April 2013 by University Hospital, Basel, Switzerland
Sponsor:
University Hospital, Basel, Switzerland
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: April 25, 2013
Last verified: April 2013
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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: | April 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:
- 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
Contacts and Locations
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
| 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: | April 25, 2013 |
| 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 Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013