Back to resultsStudy of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
Primary Purpose
Toxic Epidermal Necrolysis
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Remicaide (infliximab)
Sponsored by
About this trial
This is an interventional treatment trial for Toxic Epidermal Necrolysis focused on measuring toxic epidermal necrlysis, ten
Eligibility Criteria
Inclusion Criteria:
- Admission to burn unit with a histologic diagnosis of TENs
Exclusion Criteria:
- Pregnancy
- hypersensitivity to remicaide
- history of heart failure
- documented bacteremia
- history of cancer
- inability to consent
Sites / Locations
Outcomes
Primary Outcome Measures
30 day mortality
Secondary Outcome Measures
Safety labs and adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00372723
Brief Title
Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
Official Title
Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
slow enrollment
Study Start Date
July 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loyola University
4. Oversight
5. Study Description
Brief Summary
To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.
Detailed Description
This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxic Epidermal Necrolysis
Keywords
toxic epidermal necrlysis, ten
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Remicaide (infliximab)
Intervention Description
a single dose infusion of 5mg/kg Remicade (Infliximab)
Primary Outcome Measure Information:
Title
30 day mortality
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Safety labs and adverse events
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admission to burn unit with a histologic diagnosis of TENs
Exclusion Criteria:
Pregnancy
hypersensitivity to remicaide
history of heart failure
documented bacteremia
history of cancer
inability to consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gamelli, MD
Organizational Affiliation
Loyola University Medical Center, Department of Surgery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
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