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Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)

This study has been withdrawn prior to enrollment.
(slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00372723
First received: September 5, 2006
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Toxic Epidermal Necrolysis
 Drug: Remicaide (infliximab)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis

Resource links provided by NLM:

Drug Information available for: Infliximab
U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety labs and adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Remicaide (infliximab)
    a single dose infusion of 5mg/kg Remicade (Infliximab)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372723

Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Richard Gamelli, MD Loyola University Medical Center, Department of Surgery
  More Information

No publications provided

Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00372723     History of Changes
Other Study ID Numbers: 108983
Study First Received: September 5, 2006
Last Updated: April 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
toxic epidermal necrlysis
ten

Additional relevant MeSH terms:
Epidermal Necrolysis, Toxic
Staphylococcal Scalded Skin Syndrome
Drug Eruptions
Dermatitis
Skin Diseases
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug Toxicity
Poisoning
Substance-Related Disorders
Staphylococcal Skin Infections
Staphylococcal Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases, Infectious
Infection
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013