Intravenous Immunoglobulin G Therapy in Streptococcal Toxic Shock Syndrome: A European Randomized, Double-Blind, Placebo-Controlled Trial

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 r...

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Bibliographic Details
Published in:Clinical infectious diseases 2003-08, Vol.37 (3), p.333-340
Main Authors: Darenberg, Jessica, Ihendyane, Nahla, Sjölin, Jan, Aufwerber, Ewa, Haidl, Sven, Follin, Per, Andersson, Jan, Norrby-Teglund, Anna
Format: Article
Language:English
Subjects:
Adjuvant therapy
Adult
Aged
Aged, 80 and over
Clinical Medicine
Cytokines
Double-Blind Method
Female
Humans
Immunoglobulin G - therapeutic use
Immunoglobulins
Immunoglobulins, Intravenous
Infections
Infectious Medicine
Infektionsmedicin
Klinisk medicin
Major Articles
Male
Medical and Health Sciences
MEDICIN
Medicin och hälsovetenskap
MEDICINE
Middle Aged
Mortality
Placebos
Shock, Septic - microbiology
Shock, Septic - mortality
Shock, Septic - therapy
Sofas
Streptococcal infections
Streptococcal Infections - mortality
Streptococcal Infections - therapy
Streptococcus
Superantigens
Toxicity
Treatment Outcome
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Summary: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.
ISSN:1058-4838
1537-6591
1537-6591
DOI:10.1086/376630