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  3. 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)

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)

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Welte, T
  • Dellinger, RP
  • Ebelt, H
  • Ferrer, M
  • Opal, SM
  • Singer, M
  • Vincent, JL
  • Werdan, K
  • Martin-Loeches, I
  • Almirall, J
  • Artigas, A
  • Ayestaran, JI
  • Nuding, S
  • Ferrer, R
  • Rodriguez, GS
  • Shankar-Hari, M
  • Alvarez-Lerma, F
  • Riessen, R
  • Sirvent, JM
  • Kluge, S
  • Zacharowski, K
  • Lapp, H
  • Wobker, G
  • Achtzehn, U
  • Brealey, D
  • Kempa, A
  • Garcia, MS
  • Brederlau, J
  • Kochanek, M
  • Reschreiter, HP
  • Wise, MP
  • Belohradsky, BH
  • Bobenhausen, I
  • Dalken, B
  • Dubovy, P
  • Langohr, P
  • Mayer, M
  • Schuttrumpf, J
  • Wartenberg-Demand, A
  • Wippermann, U
  • Wolf, D
  • Torres, A

Grupos

Abstract

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.

Datos de la publicación

ISSN/ISSNe:
0342-4642, 1432-1238

INTENSIVE CARE MEDICINE  SPRINGER

Tipo:
Article
Páginas:
438-448
Factor de Impacto:
3,654 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 74

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Keywords

  • Trimodulin; Polyclonal antibody; Severe community-acquired pneumonia; Add-on therapy; Immunoglobulin M

Proyectos asociados

ENSAYO CLINICO EN FASE IV ALEATORIZADO, ABIERTO, MULTICENTRICO Y DE NO INFERIORIDAD PARA COMPARAR LA SEGURIDAD Y LA EFICACIA DE COLISTINA IV. CON MEROPENEM IV. EN EL TRATAMIENTO DE LA NEUMONIA ASOCIADA A VENTILACION MECANICA

Investigador Principal: JUAN MANUEL BONASTRE MORA

MAGICBULLET/COLOMER

ESTUDIO OBSERVACIONAL, PROSPECTIVO Y MULTICÉNTRICO EN CUIDADOS INTENSIVOS PARA EVALUAR LA FIABILIDAD DIAGNÓSTICOA DE LA PCR (REACCIÓN EN CADENA DE LA POLIMERASA) EN PACIENTES EN TRATAMIENTO ANTIFÚNGICO EMPÍRICO POR SOSPECHA DE CANDIDIASIS INVASIVA. (ESTUD IO MICAFEM).

Investigador Principal: PAULA RAMÍREZ GALLEYMORE

AST-INF-2012-01

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