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

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Brief Title

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

Official Title

Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

30 day mortality

Secondary Outcome

 Safety labs and adverse events

Condition

Toxic Epidermal Necrolysis

Intervention

Remicaide (infliximab)


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

July 2006

Completion Date

June 2011

Primary Completion Date

June 2011

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Richard Gamelli, MD, , 



Administrative Informations


NCT ID

NCT00372723

Organization ID

108983


Responsible Party

Sponsor

Study Sponsor

Loyola University


Study Sponsor

Richard Gamelli, MD, Principal Investigator, Loyola University Medical Center, Department of Surgery


Verification Date

April 2013