Necrotizing Soft Tissue Infections MedDRA version: 16.1 Level: LLT Classification code 10055648 Term: Necrotizing fasciitis fungal System Organ Class: 10021881 - Infections and infestations MedDRA version: 16.1 Level: PT Classification code 10052892 Term: Necrotising fasciitis fungal System Organ Class: 10021881 - Infections and infestations MedDRA version: 16.1 Level: LLT Classification code 10055647 Term: Necrotizing fasciitis System Organ Class: 10021881 - Infections and infestations MedD
Conditions
Interventions
Trade Name: Privigen 100 mg/ml solution for infusion
Pharmaceutical Form: Infusion
INN or Proposed INN: Human normal immunoglobulin (IVIg)
CAS Number: 308067-58-5
Other descriptive name: IMMUNOGLOBULI
Sponsors
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the effect of intravenous, polyspecific immunoglobulin G compared with placebo on the patient reported outcome measure Physical Component Summary Score (PCS) of the Short Form-36 (SF-36) in patients with necrotizing soft tissue infections.;Secondary Objective: To estimate the frequency of serious adverse reactions for intravenous, polyspecific immunoglobulin G in patients with necrotizing soft tisse infections.;Primary end point(s): Physical Component Summary Score (PCS) of Short Form-36 (SF-36);Timepoint(s) of evaluation of this end point: Six months after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 28, 90 and 180 days (mortality) Varying (time to resolution of shock) In the ICU (severe bleeding as clinical bleeding and use of 3 units of RBCs within 24 hours) In the ICU (any bleeding in the ICU) In the ICU (use of blood products (total volumes during the ICU admission)) Day 1-7 (SOFA scores (AUC), excluding the GCS score) In the ICU (use of RRT, ventilation and vasopressor) Day 1-90 (days alive off life support) Day 1-180 (days alive and out of hospital) Day 1-180 (need for amputation) In the ICU (SARs) ;Secondary end point(s): Mortality at 28, 90 and 180 days Time to resolution of shock Severe bleeding as clinical bleeding and use of 3 units of RBCs within 24 hours at any time in the ICU Any bleeding in the ICU Use of blood products (total volumes during the ICU admission) SOFA scores days 1-7 (AUC), excluding the GCS score Use of RRT, ventilation and vasopressor in the ICU Days alive off life support in the 90 days after randomisation Days alive and out of hospital in the 180 day follow-up period Amputation, any location, within 180 days SARs in the ICU (allergic reactions, haemolytic anaemia, aseptic meningitis syndrome, thrombi, transmittable agents and acute kidney injury as noted in the SPC for Privigen) | — |
Countries
Denmark
Contacts
Public ContactForskningskontoret
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
Outcome results
None listed