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

Details

Serval ID
serval:BIB_54D3DF95266B
Type
Article: article from journal or magazin.
Collection
Publications
Title
Corticosteroid treatment for community-acquired pneumonia--the STEP trial: study protocol for a randomized controlled trial.
Journal
Trials
Author(s)
Blum C.A., 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.
ISSN
1745-6215 (Electronic)
ISSN-L
1745-6215
Publication state
Published
Issued date
28/06/2014
Peer-reviewed
Oui
Volume
15
Pages
257
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: epublish
Abstract
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.
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.
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.
7 September 2009 on ClinicalTrials.gov: NCT00973154.
Keywords
Adrenal Cortex Hormones/administration & dosage, Adrenal Cortex Hormones/adverse effects, Adrenal Cortex Hormones/therapeutic use, Anti-Bacterial Agents/therapeutic use, Anti-Inflammatory Agents/administration & dosage, Anti-Inflammatory Agents/adverse effects, Anti-Inflammatory Agents/therapeutic use, Clinical Protocols, Community-Acquired Infections/diagnosis, Community-Acquired Infections/drug therapy, Community-Acquired Infections/mortality, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Humans, Intention to Treat Analysis, Pneumonia, Bacterial/diagnosis, Pneumonia, Bacterial/drug therapy, Pneumonia, Bacterial/mortality, Prednisone/administration & dosage, Prednisone/adverse effects, Prednisone/therapeutic use, Research Design, Switzerland, Time Factors, Treatment Outcome
Pubmed
Web of science
Open Access
Yes
Create date
31/01/2019 12:27
Last modification date
20/08/2019 15:09
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