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Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

NCT02111161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-09-30

No results posted yet for this study

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).

Conditions

  • Necrotizing Soft Tissue Infection
  • Necrotizing Fasciitis
  • Gas Gangrene
  • Fournier Gangrene

Interventions

DRUG

IVIG (Privigen)

Three doses of 25 g IVIG (250 ml)

DRUG

Saline 0.9%

Three doses of Saline 0.9% (250 ml)

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Anders Perner

    lead OTHER

Principal Investigators

  • Anders Perner, Professor · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02111161 on ClinicalTrials.gov