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

Loyola University

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Toxic Epidermal Necrolysis

Interventions

Remicaide (infliximab)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

30 day mortality

Time frame: 30 days

Secondary Outcomes

Safety labs and adverse events

Time frame: 30 days

Data from ClinicalTrials.gov

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