Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Perner
• Collaborator: CSL Behring
• Treatments: Antibodies; gamma-Globulins; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

Criteria

Inclusion Criteria:

• Necrotizing soft tissue infection (NSTI) based on surgical findings

• Age >18 years

• Admitted to or planned to be admitted to the ICU at Rigshospitalet (RH)

Exclusion Criteria:

• >48 hour from the primary diagnosis to arrival at RH

• More than one dose of IVIG given within current admission

• Known hypersensitivity to IVIG

• Hyperprolinaemia (obtained from hospital notes)

• Pregnancy or breast feeding