Science and Research

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)

PURPOSE: The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 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 (
  • Welte, T.
  • Dellinger, R. P.
  • Ebelt, H.
  • Ferrer, M.
  • Opal, S. M.
  • Singer, M.
  • Vincent, J. L.
  • Werdan, K.
  • Martin-Loeches, I.
  • Almirall, J.
  • Artigas, A.
  • Ignacio Ayestaran, J.
  • Nuding, S.
  • Ferrer, R.
  • Sirgo Rodriguez, G.
  • Shankar-Hari, M.
  • Alvarez-Lerma, F.
  • Riessen, R.
  • Sirvent, J. M.
  • Kluge, S.
  • Zacharowski, K.
  • Bonastre Mora, J.
  • Lapp, H.
  • Wobker, G.
  • Achtzehn, U.
  • Brealey, D.
  • Kempa, A.
  • Sanchez Garcia, M.
  • Brederlau, J.
  • Kochanek, M.
  • Reschreiter, H. P.
  • Wise, M. P.
  • Belohradsky, B. H.
  • Bobenhausen, I.
  • Dalken, B.
  • Dubovy, P.
  • Langohr, P.
  • Mayer, M.
  • Schuttrumpf, J.
  • Wartenberg-Demand, A.
  • Wippermann, U.
  • Wolf, D.
  • Torres, A.
  • Keywords

    • *Add-on therapy
    • *Immunoglobulin M
    • *Polyclonal antibody
    • *Severe community-acquired pneumonia
    • *Trimodulin
    Publication details
    DOI: 10.1007/s00134-018-5143-7
    Journal: Intensive care medicine
    Pages: 438-448 
    Number: 4
    Work Type: Original
    Location: BREATH
    Disease Area: PALI
    Partner / Member: MHH
    Access-Number: 29632995
    See publication on PubMed

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