Status:
COMPLETED
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Kantonsspital Aarau
Kantonsspital Liestal
Conditions:
Community-acquired Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 expos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT00973154
Start Date
December 1 2009
End Date
December 1 2014
Last Update
April 21 2015
Active Locations (7)
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1
Medizinische Klinik, Kantonsspital Liestal
Liestal, Basel-Landschaft, Switzerland, 4410
2
Medicine Interne, Hôpital du Jura, site de Delémont
Delémont, Canton of Jura, Switzerland, 2800
3
Kantonsspital Aarau
Aarau, Switzerland
4
University Hospital Basel
Basel, Switzerland, 4031