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

NCT ID: NCT00372723

Last Updated: 2013-04-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-06-30

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.

Conditions

Toxic Epidermal Necrolysis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Remicaide (infliximab)

a single dose infusion of 5mg/kg Remicade (Infliximab)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Gamelli, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University Medical Center, Department of Surgery

Other Identifiers

108983

Identifier Type: -

Identifier Source: org_study_id