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Repisalud author Welte, Tobias author Dellinger, R. Phillip author Ebelt, Henning author Ferrer, Miguel D author Opal, Steven M author Singer, Mervyn author Vincent, Jean-Louis author Werdan, Karl author Martin-Loeches, Ignacio author Almirall, Jordi author Artigas, Antonio author Ignacio Ayestaran, Jose author Nuding, Sebastian author Ferrer, Ricard author Sirgo Rodriguez, Gonzalo author Shankar-Hari, Manu author Alvarez-Lerma, Francisco author Riessen, Reimer author Sirvent, Josep-Maria author Kluge, Stefan author Zacharowski, Kai author Bonastre Mora, Juan author Lapp, Harald author Woebker, Gabriele author Achtzehn, Ute author Brealey, David author Kempa, Axel author Sanchez Garcia, Miguel author Brederlau, Joerg author Kochanek, Matthias author Reschreiter, Henrik Peer author Wise, Matthew P author Belohradsky, Bernd H author Bobenhausen, Iris author Dalken, Benjamin author Dubovy, Patrick author Langohr, Patrick author Mayer, Monika author Schuettrumpf, Joerg author Wartenberg-Demand, Andrea author Wippermann, Ulrike author Wolf, Daniele author Torres, Antoni 2024-09-06T09:53:42Z 2024-09-06T09:53:42Z 2018-04 Welte T, Dellinger RP, Ebelt H, Ferrer M, Opal SM, Singer M, et al. Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study). Intensive Care Med. 2018 Apr;44(4):438-48. Epub 2018 Apr 9. 10.1007/s00134-018-5143-7 1432-1238 0342-4642 Intensive Care Medicine http://hdl.handle.net/20.500.13003/10607 29632995 L621611467 2-s2.0-85045110708 https://hdl.handle.net/20.500.12105/22531 431171300004 Purpose: The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing similar to 23% immunoglobulin (Ig) M, similar to 21% IgA, and similar to 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). Methods: In this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; >= 70 mg/L) and/or IgM (<= 0.8 g/L). Results: Overall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [n = 81]) and placebo (mean 9.6; median 8 [n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58-78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline. Conclusions: No significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation. eng Trimodulin Polyclonal antibody Severe community-acquired pneumonia Add-on therapy Immunoglobulin M Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study) research article