Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Toxic Epidermal Necrolysis	Drug: Remicaide (infliximab)	Phase II

ChemIDplus related topics:

Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Loyola University:

Primary Outcome Measures:

30 day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety labs and adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372723

Contacts


Contact: Richard Gamelli, MD	708-327-2444	rgamell@lumc.edu

Contact: Gerard Abood, MD	708-327-2690	gabood@lumc.edu

Locations


United States, Illinois
	Loyola University Medical Center	Recruiting
	Maywood, Illinois, United States, 60153
	Principal Investigator: Richard Gamelli, MD

Sponsors and Collaborators

Loyola University

Investigators


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

More Information

Responsible Party:	Loyola University ( Richard Gamelli )
Study ID Numbers:	108983
First Received:	September 5, 2006
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00372723
Health Authority:	United States: Institutional Review Board

Keywords provided by Loyola University:

toxic epidermal necrlysis

ten

Study placed in the following topic categories:

Bacterial Infections

Skin Diseases

Infliximab

Poisoning

Staphylococcal Scalded Skin Syndrome

Disorders of Environmental Origin

Staphylococcal Skin Infections

Exanthema

Staphylococcal Infections

Gram-Positive Bacterial Infections

Hypersensitivity

Skin Diseases, Infectious

Drug Toxicity

Skin Diseases, Bacterial

Epidermal Necrolysis, Toxic

Drug Hypersensitivity

Toxic epidermal necrolysis

Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immune System Diseases

Drug Eruptions

Therapeutic Uses

Gastrointestinal Agents

Antirheumatic Agents

Infection

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2008

Sponsored by:	Loyola University
Information provided by:	Loyola University
ClinicalTrials.gov Identifier:	NCT00372723