Concept for a study design in patients with severe community-acquired pneumonia: A randomised controlled trial with a novel IGM-enriched immunoglobulin preparation - The CIGMA study.

Autor: Welte T; Hannover Medical School, Clinic for Pneumology and German Center of Lung Research (DZL), Carl-Neuberg-Str. 1, D-30625 Hannover, Germany. Electronic address: Welte.Tobias@mh-hannover.de., Dellinger RP; Cooper Medical School of Rowan University, Camden, NJ 08103, USA., Ebelt H; St. Johann Nepomuk Hospital, Haarbergstr. 72, 99097 Erfurt, Germany., Ferrer M; Servei de Pneumologia, Hospital Clínic de Barcelona, IDIBAPS, CibeRes (CB06/06/0028). Villarroel 170, 08036 Barcelona, Spain., Opal SM; Infectious Disease Division, Alpert Medical School of Brown University, Providence, RI 02860, USA., Schliephake DE; Corporate Clinical Research Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany., Wartenberg-Demand A; Corporate Clinical Research Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany., Werdan K; Department of Medicine, University Hospital Halle (Saale), Martin-Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, D-06120 Halle (Saale), Germany., Löffler K; Accovion GmbH, Helfmann-Park 10, D-65760 Eschborn, Germany., Torres A; Servei de Pneumologia, Hospital Clínic de Barcelona, Villarroel 170, 08036 Barcelona, Spain.
Jazyk: angličtina
Zdroj: Respiratory medicine [Respir Med] 2015 Jun; Vol. 109 (6), pp. 758-67. Date of Electronic Publication: 2015 Apr 02.
DOI: 10.1016/j.rmed.2015.03.008
Abstrakt: Introduction: Severe community-acquired pneumonia is defined as community-acquired pneumonia that requires intensive medical care. Mortality in these patients is still high depending on time and admission. Since bad outcomes may occur despite antibiotic therapy to treat severe community-acquired pneumonia, the focus has shifted to targeting the host response. The CIGMA Study examines the safety and efficacy of the novel IgM-enriched immunoglobulin preparation BT086 when added to standard of care treatment.
Methods/design: The aim of this multicentre, randomised, placebo-controlled, double-blind, parallel-group, adaptive group-sequential phase II study is to determine the efficacy and safety of BT086, an IgM-enriched immunoglobulin preparation, as an adjunctive treatment in mechanically-ventilated patients with severe community-acquired pneumonia. The increase of ventilator-free days is the primary endpoint in this study. For this trial, ventilator-free days are defined as the number of days between successful extubation from endotracheal ventilation and day 28 after enrolment of the patient into the study. Two interim analyses were considered for this study.
Discussion: Several novel agents for treatment of sepsis have been evaluated in the last two decades; however, none has significantly reduced mortality rates. Failure was attributed to the heterogeneity of septic patients or sepsis. Severe community-acquired pneumonia was chosen as the indication for this study to increase homogeneity within this patient population.
Trial Registration: EUDRACT 2010-022380-35.
(Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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