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Open Access Study protocol

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

Claudine A Blum1*, Nicole Nigro1, Bettina Winzeler1, Isabelle Suter-Widmer1, Philipp Schuetz2, Matthias Briel34, Roland Bingisser5, Werner Zimmerli6, Elke Ullmer6, Hanno Elsaesser6, Philip Tarr7, Sebastian Wirz7, Robert Thomann8, Eveline Hofmann9, Nicolas Rodondi9, Hervé Duplain10, Dieter Burki11, Beat Mueller2 and Mirjam Christ-Crain1

Author Affiliations

1 Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland

2 Medical University Clinic, Kantonsspital Aarau, Tellstrasse, 5001 Aarau, Switzerland

3 Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Hebelstrasse 10, 4031 Basel, Switzerland

4 Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada

5 Emergency Department, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland

6 Medical University Clinic, Kantonsspital Baselland Standort Liestal, Rheinstrasse 26, 4410 Liestal, Switzerland

7 Medical University Clinic, Kantonsspital Baselland Standort Bruderholz, 4101 Bruderholz, Switzerland

8 Clinic of Internal Medicine, Bürgerspital, Schöngrünstrasse 42, 4500 Solothurn, Switzerland

9 Department of General Internal Medicine, Inselspital, Bern University Hospital, 3010 Bern, Switzerland

10 Medical Clinic, Hôpital du Jura, Site de Delémont, Faubourg des Capucins 30, 2800 Delémont, Switzerland

11 Viollier AG, Postfach, 4002 Basel, Switzerland

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Trials 2014, 15:257  doi:10.1186/1745-6215-15-257

Published: 28 June 2014

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.

Keywords:
Corticosteroids; Community-acquired pneumonia; Pulmonary infection; Emergency medicine; Intensive care; Glucocorticoids