Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

Summary

The purpose of this study is to estimate the effect of intravenous polyspecific immunoglobulin G (IVIG) compared with placebo (saline) on the patient-reported outcome measure Physical Component Summary Score (PCS) of the SF-36 in patients with necrotizing soft tissue infections (NSTI).

Timeline

Start

2014-04

Primary completion

2016-09

Completion

2016-09

Publications

• Bergsten H, Madsen MB, Bergey F, Hyldegaard O, Skrede S, Arnell P, Oppegaard O, Itzek A, Perner A, Svensson M, Norrby-Teglund A; INFECT Study Group. Correlation Between Immunoglobulin Dose Administered and Plasma Neutralization of Streptococcal Superantigens in Patients With Necrotizing Soft Tissue Infections. Clin Infect Dis. 2020 Oct 23;71(7):1772-1775. doi: 10.1093/cid/ciaa022.
• Madsen MB, Hjortrup PB, Hansen MB, Lange T, Norrby-Teglund A, Hyldegaard O, Perner A. Immunoglobulin G for patients with necrotising soft tissue infection (INSTINCT): a randomised, blinded, placebo-controlled trial. Intensive Care Med. 2017 Nov;43(11):1585-1593. doi: 10.1007/s00134-017-4786-0. Epub 2017 Apr 18.
• Madsen MB, Lange T, Hjortrup PB, Perner A. Immunoglobulin for necrotising soft tissue infections (INSTINCT): protocol for a randomised trial. Dan Med J. 2016 Jul;63(7):A5250.

Drugs

Indications