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Trial record 12 of 17 for:    Necrotizing Fascitis

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial (INSTINCT)

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ClinicalTrials.gov Identifier: NCT02111161
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : September 30, 2016
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Anders Perner, Rigshospitalet, Denmark

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).

Condition or disease Intervention/treatment Phase
Necrotizing Soft Tissue Infection Necrotizing Fasciitis Gas Gangrene Fournier Gangrene Drug: IVIG (Privigen) Drug: Saline 0.9% Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial
Study Start Date : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Active Comparator: IVIG (Privigen)
Intravenous polyspecific immunoglobulin G (Privigen). Dosage: 25 g/day (250 ml) for three consecutive days
Drug: IVIG (Privigen)
Three doses of 25 g IVIG (250 ml)
Other Names:
  • Privigen
  • Immunoglobulin G

Placebo Comparator: Saline 0.9%
0.9% saline for Intravenous administration. Dosage: 250 ml for three consecutive days.
Drug: Saline 0.9%
Three doses of Saline 0.9% (250 ml)
Other Name: NaCl




Primary Outcome Measures :
  1. Physical Component Summary Score (PCS) of Short-Form 36 (SF-36) [ Time Frame: Six months after randomisation ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28, 90 and 180 days ]
  2. Time to resolution of shock [ Time Frame: During ICU admission (expected average of 8 days) ]
    Maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for 24 hours

  3. Severe bleeding [ Time Frame: During ICU admission (expected average of 8 days) ]
    Clinical bleeding and use of 3 units of red blood cells (RBCs) within 24 hours at any time in the ICU

  4. Any bleeding in the ICU [ Time Frame: During ICU admission (expected average of 8 days) ]
  5. Use of blood products [ Time Frame: During ICU admission ]
    Total volumes during the ICU admission

  6. SOFA scores (AUC), excluding the Glasgow Coma Score (GCS) score [ Time Frame: Day 1-7 ]
  7. Use of renal replcement therapy (RRT), ventilation and vasopressor in the ICU [ Time Frame: During ICU admission (expected average of 8 days) ]
  8. Days alive off life support in the 90 days after randomisation [ Time Frame: 90 days after randomisation ]
  9. Days alive and out of hospital in the 180 day follow-up period [ Time Frame: 180 day follow-up period ]
  10. Amputation, any location [ Time Frame: Within 180 days ]
  11. Serious Adverse Reactions (SARs) in the ICU [ Time Frame: During ICU admission (expected average of 8 days) ]
    • Allergic reactions
    • Haemolytic anaemia
    • Aseptic meningitis syndrome
    • Thrombus
    • Transmittable agents
    • Acute kidney injury



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02111161


Locations
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Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Danmark, Denmark, 2100
Sponsors and Collaborators
Anders Perner
CSL Behring
Investigators
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Principal Investigator: Anders Perner, Professor Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Perner, MD, PhD, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02111161     History of Changes
Other Study ID Numbers: RH4131-03
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by Anders Perner, Rigshospitalet, Denmark:
Randomised controlled trial (RCT)
Immunoglobulin
Patient Reported Outcome
Health-Related Quality of Life
Short Form-36 (SF-36)
Additional relevant MeSH terms:
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Fasciitis, Necrotizing
Fasciitis
Infection
Communicable Diseases
Soft Tissue Infections
Fournier Gangrene
Gas Gangrene
Gangrene
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Skin Diseases, Bacterial
Bacterial Infections
Genital Diseases, Male
Clostridium Infections
Gram-Positive Bacterial Infections
Immunoglobulins
Antibodies
Immunoglobulin G
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs