Back to resultsCorticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial (STEP)
Primary Purpose
Community-acquired Pneumonia
Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Pneumonia, Corticosteroids, clinical stability
Eligibility 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
Sites / Locations
- Medizinische Klinik, Kantonsspital Liestal
- Medicine Interne, Hôpital du Jura, site de Delémont
- Kantonsspital Aarau
- University Hospital Basel
- Inselspital
- Bruderholzspital
- Bürgerspital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prednisone
Placebo
Arm Description
Drug
Outcomes
Primary Outcome Measures
Time to clinical stability
Secondary Outcome Measures
Side effects of corticosteroids, mortality, recurrence
Full Information
NCT ID
NCT00973154
First Posted
September 7, 2009
Last Updated
April 20, 2015
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Kantonsspital Aarau, Kantonsspital Liestal
1. Study Identification
Unique Protocol Identification Number
NCT00973154
Brief Title
Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial
Acronym
STEP
Official Title
Corticosteroid Treatment for Community-Acquired Pneumonia A Randomized, Double-blind Study- The STEP Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Kantonsspital Aarau, Kantonsspital Liestal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Pneumonia, Corticosteroids, clinical stability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
50mg per day of prednisone orally for 7 days versus placebo
Primary Outcome Measure Information:
Title
Time to clinical stability
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Side effects of corticosteroids, mortality, recurrence
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirjam Christ-Crain, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik, Kantonsspital Liestal
City
Liestal
State/Province
BL
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Medicine Interne, Hôpital du Jura, site de Delémont
City
Delémont
State/Province
JU
ZIP/Postal Code
2800
Country
Switzerland
Facility Name
Kantonsspital Aarau
City
Aarau
Country
Switzerland
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital
City
Bern
Country
Switzerland
Facility Name
Bruderholzspital
City
Bruderholz
Country
Switzerland
Facility Name
Bürgerspital
City
Solothurn
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
35322019
Citation
Borisov AN, Blum CA, Christ-Crain M, Ebrahimi F. No obesity paradox in patients with community-acquired pneumonia - secondary analysis of a randomized controlled trial. Nutr Diabetes. 2022 Mar 23;12(1):12. doi: 10.1038/s41387-022-00190-7.
Results Reference
derived
PubMed Identifier
33980941
Citation
Sailer CO, Refardt J, Blum CA, Schnyder I, Molina-Tijeras JA, Fenske W, Christ-Crain M. Validity of different copeptin assays in the differential diagnosis of the polyuria-polydipsia syndrome. Sci Rep. 2021 May 12;11(1):10104. doi: 10.1038/s41598-021-89505-9.
Results Reference
derived
PubMed Identifier
31952985
Citation
Potasso L, Sailer CO, Blum CA, Cesana-Nigro N, Schuetz P, Mueller B, Christ-Crain M. Mild to moderate hyponatremia at discharge is associated with increased risk of recurrence in patients with community-acquired pneumonia. Eur J Intern Med. 2020 May;75:44-49. doi: 10.1016/j.ejim.2019.12.009. Epub 2020 Jan 15.
Results Reference
derived
PubMed Identifier
31340056
Citation
Popovic M, Cesana-Nigro N, Winzeler B, Thomann R, Schutz P, Muller B, Christ-Crain M, Blum CA. Estimation of treatment allocation in a randomised, double-blinded, placebo-controlled trial. Swiss Med Wkly. 2019 Jul 24;149:w20114. doi: 10.4414/smw.2019.20114. eCollection 2019 Jul 15.
Results Reference
derived
PubMed Identifier
30485501
Citation
Blum CA, Schuetz P, Nigro N, Winzeler B, Arici B, Refardt J, Urwyler SA, Rodondi N, Blum MR, Briel M, Mueller B, Christ-Crain M. Cosyntropin testing does not predict response to glucocorticoids in community-acquired pneumonia in a randomized controlled trial. Clin Endocrinol (Oxf). 2019 Sep;91(3):374-382. doi: 10.1111/cen.13907. Epub 2019 Jan 9.
Results Reference
derived
PubMed Identifier
27614658
Citation
Popovic M, Blum CA, Nigro N, Mueller B, Schuetz P, Christ-Crain M. Benefit of adjunct corticosteroids for community-acquired pneumonia in diabetic patients. Diabetologia. 2016 Dec;59(12):2552-2560. doi: 10.1007/s00125-016-4091-4. Epub 2016 Sep 10.
Results Reference
derived
PubMed Identifier
27471201
Citation
Wirz SA, Blum CA, Schuetz P, Albrich WC, Noppen C, Mueller B, Christ-Crain M, Tarr PE; STEP Study Group. Pathogen- and antibiotic-specific effects of prednisone in community-acquired pneumonia. Eur Respir J. 2016 Oct;48(4):1150-1159. doi: 10.1183/13993003.00474-2016. Epub 2016 Jul 28.
Results Reference
derived
PubMed Identifier
25608756
Citation
Blum CA, Nigro N, Briel M, Schuetz P, Ullmer E, Suter-Widmer I, Winzeler B, Bingisser R, Elsaesser H, Drozdov D, Arici B, Urwyler SA, Refardt J, Tarr P, Wirz S, Thomann R, Baumgartner C, Duplain H, Burki D, Zimmerli W, Rodondi N, Mueller B, Christ-Crain M. Adjunct prednisone therapy for patients with community-acquired pneumonia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2015 Apr 18;385(9977):1511-8. doi: 10.1016/S0140-6736(14)62447-8. Epub 2015 Jan 19.
Results Reference
derived
PubMed Identifier
24974155
Citation
Blum CA, Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Briel M, Bingisser R, Zimmerli W, Ullmer E, Elsaesser H, Tarr P, Wirz S, Thomann R, Hofmann E, Rodondi N, Duplain H, Burki D, Mueller B, Christ-Crain M. Corticosteroid treatment for community-acquired pneumonia--the STEP trial: study protocol for a randomized controlled trial. Trials. 2014 Jun 28;15:257. doi: 10.1186/1745-6215-15-257.
Results Reference
derived
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Corticosteroid Treatment for Community-Acquired Pneumonia - The STEP Trial
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