Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
April 25, 2013 updated by: Loyola University
Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
30 day mortality
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety labs and adverse events
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Gamelli, MD, Loyola University Medical Center, Department of Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
September 5, 2006
First Submitted That Met QC Criteria
September 6, 2006
First Posted (Estimate)
September 7, 2006
Study Record Updates
Last Update Posted (Estimate)
April 26, 2013
Last Update Submitted That Met QC Criteria
April 25, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Skin Diseases
- Immune System Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Hypersensitivity
- Erythema
- Skin Diseases, Vesiculobullous
- Dermatitis
- Drug-Related Side Effects and Adverse Reactions
- Stomatitis
- Drug Eruptions
- Erythema Multiforme
- Drug Hypersensitivity
- Stevens-Johnson Syndrome
- Antirheumatic Agents
- Gastrointestinal Agents
- Dermatologic Agents
- Infliximab
Other Study ID Numbers
- 108983
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.