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Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome: A European randomized, double-blind, placebo-controlled trial

Darenberg, J ; Ihendyane, N ; Sjolin, J ; Aufwerber, E ; Haidl, Sven LU ; Follin, P ; Andersson, J and Norrby-Teglund, A (2003) In Clinical Infectious Diseases 37(3). p.333-340
Abstract
The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G (IVIG) as adjunctive therapy in streptococcal toxic shock syndrome (STSS) were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial. The trial was prematurely terminated because of slow patient recruitment, and results were obtained from 21 enrolled patients (10 IVIG recipients and 11 placebo recipients). The primary end point was mortality at 28 days, and a 3.6-fold higher mortality rate was found in the placebo group. A significant decrease in the sepsis-related organ failure assessment score at days 2 (P = .02) and 3 (P = .04) was noted in the IVIG group. Furthermore, a significant increase in plasma neutralizing activity against... (More)
The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G (IVIG) as adjunctive therapy in streptococcal toxic shock syndrome (STSS) were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial. The trial was prematurely terminated because of slow patient recruitment, and results were obtained from 21 enrolled patients (10 IVIG recipients and 11 placebo recipients). The primary end point was mortality at 28 days, and a 3.6-fold higher mortality rate was found in the placebo group. A significant decrease in the sepsis-related organ failure assessment score at days 2 (P = .02) and 3 (P = .04) was noted in the IVIG group. Furthermore, a significant increase in plasma neutralizing activity against superantigens expressed by autologous isolates was noted in the IVIG group after treatment (P = .03). Although statistical significance was not reached in the primary end point, the trial provides further support for IVIG as an efficacious adjunctive therapy in STSS. (Less)
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author
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Clinical Infectious Diseases
volume
37
issue
3
pages
333 - 340
publisher
Oxford University Press
external identifiers
  • pmid:12884156
  • wos:000184407900003
  • scopus:0041402681
ISSN
1537-6591
DOI
10.1086/376630
language
English
LU publication?
yes
id
33f28498-a21c-4860-977c-af8157750891 (old id 900117)
date added to LUP
2016-04-01 11:46:56
date last changed
2022-03-20 18:49:58
@article{33f28498-a21c-4860-977c-af8157750891,
  abstract     = {{The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G (IVIG) as adjunctive therapy in streptococcal toxic shock syndrome (STSS) were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial. The trial was prematurely terminated because of slow patient recruitment, and results were obtained from 21 enrolled patients (10 IVIG recipients and 11 placebo recipients). The primary end point was mortality at 28 days, and a 3.6-fold higher mortality rate was found in the placebo group. A significant decrease in the sepsis-related organ failure assessment score at days 2 (P = .02) and 3 (P = .04) was noted in the IVIG group. Furthermore, a significant increase in plasma neutralizing activity against superantigens expressed by autologous isolates was noted in the IVIG group after treatment (P = .03). Although statistical significance was not reached in the primary end point, the trial provides further support for IVIG as an efficacious adjunctive therapy in STSS.}},
  author       = {{Darenberg, J and Ihendyane, N and Sjolin, J and Aufwerber, E and Haidl, Sven and Follin, P and Andersson, J and Norrby-Teglund, A}},
  issn         = {{1537-6591}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{333--340}},
  publisher    = {{Oxford University Press}},
  series       = {{Clinical Infectious Diseases}},
  title        = {{Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome: A European randomized, double-blind, placebo-controlled trial}},
  url          = {{http://dx.doi.org/10.1086/376630}},
  doi          = {{10.1086/376630}},
  volume       = {{37}},
  year         = {{2003}},
}