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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

Corticosteroid treatment for community-acquired pneumonia - the STEP trial: study protocol for a randomized controlled trial

Authors: Claudine A Blum, Nicole Nigro, Bettina Winzeler, Isabelle Suter-Widmer, Philipp Schuetz, Matthias Briel, Roland Bingisser, Werner Zimmerli, Elke Ullmer, Hanno Elsaesser, Philip Tarr, Sebastian Wirz, Robert Thomann, Eveline Hofmann, Nicolas Rodondi, Hervé Duplain, Dieter Burki, Beat Mueller, Mirjam Christ-Crain

Published in: Trials | Issue 1/2014

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Abstract

Background

Community-acquired pneumonia (CAP) is the third-leading infectious cause of death worldwide. The standard treatment of CAP has not changed for the past fifty years and its mortality and morbidity remain high despite adequate antimicrobial treatment. Systemic corticosteroids have anti-inflammatory effects and are therefore discussed as adjunct treatment for CAP. Available studies show controversial results, and the question about benefits and harms of adjunct corticosteroid therapy has not been conclusively resolved, particularly in the non-critical care setting.

Methods/Design

This randomized multicenter study compares a treatment with 7 days of prednisone 50 mg with placebo in adult patients hospitalized with CAP independent of severity. Patients are screened and enrolled within the first 36 hours of presentation after written informed consent is obtained. The primary endpoint will be time to clinical stability, which is assessed every 12 hours during hospitalization. Secondary endpoints will be, among others, all-cause mortality within 30 and 180 days, ICU stay, duration of antibiotic treatment, disease activity scores, side effects and complications, value of adrenal function testing and prognostic hormonal and inflammatory biomarkers to predict outcome and treatment response to corticosteroids. Eight hundred included patients will provide an 85% power for the intention-to-treat analysis of the primary endpoint.

Discussion

This largest to date double-blind placebo-controlled multicenter trial investigates the effect of adjunct glucocorticoids in 800 patients with CAP requiring hospitalization. It aims to give conclusive answers about benefits and risks of corticosteroid treatment in CAP. The inclusion of less severe CAP patients will be expected to lead to a relatively low mortality rate and survival benefit might not be shown. However, our study has adequate power for the clinically relevant endpoint of clinical stability. Due to discontinuing glucocorticoids without tapering after seven days, we limit duration of glucocorticoid exposition, which may reduce possible side effects.

Trial registration

7 September 2009 on ClinicalTrials.gov: NCT00973154.
Appendix
Available only for authorised users
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Metadata
Title
Corticosteroid treatment for community-acquired pneumonia - the STEP trial: study protocol for a randomized controlled trial
Authors
Claudine A Blum
Nicole Nigro
Bettina Winzeler
Isabelle Suter-Widmer
Philipp Schuetz
Matthias Briel
Roland Bingisser
Werner Zimmerli
Elke Ullmer
Hanno Elsaesser
Philip Tarr
Sebastian Wirz
Robert Thomann
Eveline Hofmann
Nicolas Rodondi
Hervé Duplain
Dieter Burki
Beat Mueller
Mirjam Christ-Crain
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-257

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