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

• Sponsor: Loyola University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00372723
• Collaborator: (none)
• Enrollment: 0
• Duration (Months): 59

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Toxic Epidermal Necrolysis	Drug: Remicaide (infliximab)	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Outcome Measures

Primary Outcome Measures

1. 30 day mortality [30 days]

Secondary Outcome Measures

1. Safety labs and adverse events [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Loyola University

Investigators

• Principal Investigator: Richard Gamelli, MD, Loyola University Medical Center, Department of Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loyola University
• ClinicalTrials.gov Identifier: NCT00372723
• Other Study ID Numbers: 108983
• First Posted: Sep 7, 2006
• Last Update Posted: Apr 26, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Loyola University: toxic epidermal necrlysis; ten
• Additional relevant MeSH terms: Stevens-Johnson Syndrome; Infliximab

Study Results

No Results Posted as of Apr 26, 2013