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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00372723
Date of registration: 05/09/2006
Prospective Registration: Yes
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Recruitment status: Withdrawn
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
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
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)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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