title: Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome: a European randomized, double-blind, placebo-controlled trial.
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.
authors.affiliation: Center for Infectious Medicine, Department of Medicine, Karolinska Institutet, Huddinge University Hospital, S-141 86 Stockholm, Sweden.
authors.forename: Jessica
authors.initials: J
authors.lastname: Darenberg
authors.forename: Nahla
authors.initials: N
authors.lastname: Ihendyane
authors.forename: Jan
authors.initials: J
authors.lastname: Sjölin
authors.forename: Ewa
authors.initials: E
authors.lastname: Aufwerber
authors.forename: Sven
authors.initials: S
authors.lastname: Haidl
authors.forename: Per
authors.initials: P
authors.lastname: Follin
authors.forename: Jan
authors.initials: J
authors.lastname: Andersson
authors.forename: Anna
authors.initials: A
authors.lastname: Norrby-Teglund
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D016756:Immunoglobulins, Intravenous; D008297:Male; D008875:Middle Aged; D012772:Shock, Septic / Q000382:microbiology / Q000401:mortality / Q000628:therapy*; D013290:Streptococcal Infections / Q000401:mortality / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D007074:Immunoglobulin G; D016756:Immunoglobulins, Intravenous