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

Loyola University

Status and phase: Withdrawn; Phase 2

Conditions: Toxic Epidermal Necrolysis

Treatments: Drug: Remicaide (infliximab)

Study type: Interventional

Funder types: Other

Identifiers

NCT00372723

108983

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)