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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Staphylococcal Scalded Skin Syndrome
Stevens-Johnson Syndrome
Bacterial Infections
Chemically-Induced Disorders
Dermatitis
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Erythema
Erythema Multiforme
Gram-Positive Bacterial Infections
Hypersensitivity
Immune System Diseases
Infection
Mouth Diseases
Skin Diseases
Skin Diseases, Bacterial
Skin Diseases, Infectious
Skin Diseases, Vesiculobullous
Staphylococcal Infections
Staphylococcal Skin Infections
Stomatitis
Stomatognathic Diseases
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2014