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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00372723
• Date of registration: 05/09/2006
• Prospective Registration: No
• Primary sponsor: Loyola University
• Public title: Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)
• Scientific title: Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis
• Date of first enrolment: July 2006
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT00372723
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Richard Gamelli, MD
• Affiliation: Loyola University Medical Center, Department of Surgery

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Toxic Epidermal Necrolysis

Intervention(s)

Drug: Remicaide (infliximab)

Primary Outcome(s)

30 day mortality [Time Frame: 30 days]

Secondary Outcome(s)

Safety labs and adverse events [Time Frame: 30 days]

Secondary ID(s)

108983

Source(s) of Monetary Support

Please refer to primary and secondary sponsors