Immunoglobulin for Necrotizing Soft Tissue Infections

Phase 1

Conditions: MedDRA version: 16.1Level: PTClassification code 10028885Term: Necrotising fasciitisSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.1Level: LLTClassification code 10016229Term: Fasciitis necrotisingSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.1Level: LLTClassification code 10028886Term: Necrotising fasciitis NOSSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.1Level: PTClassification code 10028888Term: Necrotising fasciitis streptococcalSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.1Level: PTClassification code 10028887Term: Necrotising fasciitis staphylococcalSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.1Level: LLTClassification code 10055650Term: Necrotizing fasciitis streptococcalSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 16.1Level: LLTClassification code 10055643Term: Fasciitis necrotizingSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
ecrotizing Soft Tissue Infections
MedDRA version: 16.1Level: LLTClassification code 10055648Term: Necrotizing fasciitis fungalSystem Organ Class: 10021881 - Infections and infestations

Registration Number: EUCTR2013-003556-20-DK

Lead Sponsor: Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Necrotizing soft tissue infection based on surgical findings
Age >=18 years
Admitted to or planned to be admitted to the ICU at Copenhagen University Hospital, Rigshospitalet

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

•>48 hour from the primary diagnosis to arrival at Copenhagen University Hospital, Rigshospitalet
•More than one dose of intavenous, polyspecific immunoglobulin G (IVIG) given within current admission
•Known hypersensitivity to IVIG
•Hyperprolinaemia
•Pregnancy or breast feeding