title: Corticosteroid treatment for community-acquired pneumonia--the STEP trial: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  7 September 2009 on ClinicalTrials.gov: NCT00973154.
authors: Endocrinology, Diabetology and Metabolism, Department of Internal Medicine, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland. claudineblum@yahoo.com.
authors: Claudine A
authors: CA
authors: Blum
authors: Nicole
authors: N
authors: Nigro
authors: Bettina
authors: B
authors: Winzeler
authors: Isabelle
authors: I
authors: Suter-Widmer
authors: Philipp
authors: P
authors: Schuetz
authors: Matthias
authors: M
authors: Briel
authors: Roland
authors: R
authors: Bingisser
authors: Werner
authors: W
authors: Zimmerli
authors: Elke
authors: E
authors: Ullmer
authors: Hanno
authors: H
authors: Elsaesser
authors: Philip
authors: P
authors: Tarr
authors: Sebastian
authors: S
authors: Wirz
authors: Robert
authors: R
authors: Thomann
authors: Eveline
authors: E
authors: Hofmann
authors: Nicolas
authors: N
authors: Rodondi
authors: Hervé
authors: H
authors: Duplain
authors: Dieter
authors: D
authors: Burki
authors: Beat
authors: B
authors: Mueller
authors: Mirjam
authors: M
authors: Christ-Crain
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D017714:Community-Acquired Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D006801:Humans; D057194:Intention to Treat Analysis; D018410:Pneumonia, Bacterial / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D011241:Prednisone