Claudine Angela Blum1, Nicole Nigro2, Matthias Briel3, Philipp Schuetz4, Elke Ullmer5, Isabelle Suter-Widmer2, Bettina Winzeler2, Roland Bingisser6, Hanno Elsaesser5, Daniel Drozdov4, Birsen Arici1, Sandrine Andrea Urwyler2, Julie Refardt2, Philip Tarr7, Sebastian Wirz7, Robert Thomann8, Christine Baumgartner9, Hervé Duplain10, Dieter Burki11, Werner Zimmerli5, Nicolas Rodondi9, Beat Mueller4, Mirjam Christ-Crain12. 1. Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland; Medical University Clinic, Departments of Internal and Emergency Medicine and Department of Endocrinology, Diabetology and Clinical Nutrition, Kantonsspital Aarau, Aarau, Switzerland. 2. Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland. 3. Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, Basel, Switzerland; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada. 4. Medical University Clinic, Departments of Internal and Emergency Medicine and Department of Endocrinology, Diabetology and Clinical Nutrition, Kantonsspital Aarau, Aarau, Switzerland. 5. Medical University Clinic, Kantonsspital Baselland/Liestal, Liestal, Switzerland. 6. Emergency Department, University Hospital Basel, Basel, Switzerland. 7. Medical University Clinic, Kantonsspital Baselland/Bruderholz, Bruderholz, Switzerland. 8. Department of Internal Medicine, Bürgerspital, Solothurn, Switzerland. 9. Department of General Internal Medicine, Inselspital, Bern University Hospital, Bern, Switzerland. 10. Clinic of Internal Medicine, Hôpital du Jura, Site de Delémont, Delémont, Switzerland. 11. Viollier AG, Postfach, Basel, Switzerland. 12. Endocrinology, Diabetology and Metabolism, Department of Internal Medicine and Department of Clinical Research, University Hospital Basel, Basel, Switzerland. Electronic address: mirjam.christ@usb.ch.
Abstract
BACKGROUND: Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia. We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia. METHODS: In this double-blind, multicentre, randomised, placebo-controlled trial, we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation. Patients were randomly assigned (1:1 ratio) to receive either prednisone 50 mg daily for 7 days or placebo. The computer-generated randomisation was done with variable block sizes of four to six and stratified by study centre. The primary endpoint was time to clinical stability defined as time (days) until stable vital signs for at least 24 h, and analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00973154. FINDINGS: From Dec 1, 2009, to May 21, 2014, of 2911 patients assessed for eligibility, 785 patients were randomly assigned to either the prednisone group (n=392) or the placebo group (n=393). Median time to clinical stability was shorter in the prednisone group (3·0 days, IQR 2·5-3·4) than in the placebo group (4·4 days, 4·0-5·0; hazard ratio [HR] 1·33, 95% CI 1·15-1·50, p<0·0001). Pneumonia-associated complications until day 30 did not differ between groups (11 [3%] in the prednisone group and 22 [6%] in the placebo group; odds ratio [OR] 0·49 [95% CI 0·23-1·02]; p=0·056). The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment (76 [19%] vs 43 [11%]; OR 1·96, 95% CI 1·31-2·93, p=0·0010). Other adverse events compatible with corticosteroid use were rare and similar in both groups. INTERPRETATION:Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications. This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency. FUNDING: Swiss National Science Foundation, Viollier AG, Nora van Meeuwen Haefliger Stiftung, Julia und Gottfried Bangerter-Rhyner Stiftung.
RCT Entities:
BACKGROUND: Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia. We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia. METHODS: In this double-blind, multicentre, randomised, placebo-controlled trial, we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation. Patients were randomly assigned (1:1 ratio) to receive either prednisone 50 mg daily for 7 days or placebo. The computer-generated randomisation was done with variable block sizes of four to six and stratified by study centre. The primary endpoint was time to clinical stability defined as time (days) until stable vital signs for at least 24 h, and analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00973154. FINDINGS: From Dec 1, 2009, to May 21, 2014, of 2911 patients assessed for eligibility, 785 patients were randomly assigned to either the prednisone group (n=392) or the placebo group (n=393). Median time to clinical stability was shorter in the prednisone group (3·0 days, IQR 2·5-3·4) than in the placebo group (4·4 days, 4·0-5·0; hazard ratio [HR] 1·33, 95% CI 1·15-1·50, p<0·0001). Pneumonia-associated complications until day 30 did not differ between groups (11 [3%] in the prednisone group and 22 [6%] in the placebo group; odds ratio [OR] 0·49 [95% CI 0·23-1·02]; p=0·056). The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment (76 [19%] vs 43 [11%]; OR 1·96, 95% CI 1·31-2·93, p=0·0010). Other adverse events compatible with corticosteroid use were rare and similar in both groups. INTERPRETATION:Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications. This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency. FUNDING: Swiss National Science Foundation, Viollier AG, Nora van Meeuwen Haefliger Stiftung, Julia und Gottfried Bangerter-Rhyner Stiftung.
Authors: R Parra Millán; M E Jiménez Mejías; V Sánchez Encinales; R Ayerbe Algaba; A Gutiérrez Valencia; M E Pachón Ibáñez; C Díaz; J Pérez Del Palacio; L F López Cortés; J Pachón; Y Smani Journal: Antimicrob Agents Chemother Date: 2016-07-22 Impact factor: 5.191
Authors: Tom H Boyles; Adrian Brink; Greg L Calligaro; Cheryl Cohen; Keertan Dheda; Gary Maartens; Guy A Richards; Richard van Zyl Smit; Clifford Smith; Sean Wasserman; Andrew C Whitelaw; Charles Feldman Journal: J Thorac Dis Date: 2017-06 Impact factor: 2.895