NCT02111161

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

April 3, 2014

Last Update Submit

September 29, 2016

Conditions

Necrotizing Soft Tissue InfectionNecrotizing FasciitisGas GangreneFournier Gangrene

Keywords

Randomised controlled trial (RCT)ImmunoglobulinPatient Reported OutcomeHealth-Related Quality of LifeShort Form-36 (SF-36)

Outcome Measures

Primary Outcomes (1)

  • Physical Component Summary Score (PCS) of Short-Form 36 (SF-36)

    Six months after randomisation

Secondary Outcomes (11)

  • Mortality

    28, 90 and 180 days

  • Time to resolution of shock

    During ICU admission (expected average of 8 days)

  • Severe bleeding

    During ICU admission (expected average of 8 days)

  • Any bleeding in the ICU

    During ICU admission (expected average of 8 days)

  • Use of blood products

    During ICU admission

  • +6 more secondary outcomes

Study Arms (2)

IVIG (Privigen)

ACTIVE COMPARATOR

Intravenous polyspecific immunoglobulin G (Privigen). Dosage: 25 g/day (250 ml) for three consecutive days

Drug: IVIG (Privigen)

Saline 0.9%

PLACEBO COMPARATOR

0.9% saline for Intravenous administration. Dosage: 250 ml for three consecutive days.

Drug: Saline 0.9%

Interventions

IVIG (Privigen)DRUG

Three doses of 25 g IVIG (250 ml)

Also known as: Privigen, Immunoglobulin G
IVIG (Privigen)
Saline 0.9%DRUG

Three doses of Saline 0.9% (250 ml)

Also known as: NaCl
Saline 0.9%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Danmark, 2100, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 31916575DERIVED

  • 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.

    PMID: 28421246DERIVED

  • 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.

    PMID: 27399982DERIVED

MeSH Terms

Conditions

Fasciitis, NecrotizingGas GangreneFournier Gangrene

Interventions

Immunoglobulins, IntravenousImmunoglobulin GSodium Chloride

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Anders Perner, Professor

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 11, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

DK(1)