Brief Title
G-CSF in the Treatment of Toxic Epidermal Necrolysis
Official Title
Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis
Brief Summary
NeupoNET aims to evaluate interest of G-CSF in the treatment of Toxic Epidermal necrolysis. This is a prospective randomized controlled trial. Patients will be allocated in a treatment group (receiving an injection of 5 microg/kg/d of G-CSF during 5 consecutive days) or in a placebo group. Patients will be randomized at admission and will be followed until 3 months after discharge.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Time for healing
Secondary Outcome
Biological data: WBC count
Condition
Stevens - Johnson Syndrome
Intervention
recombinant granulocyte - colony stimulating factor
Study Arms / Comparison Groups
G-CSF
Description: An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4.
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
10
Start Date
July 2016
Completion Date
July 2022
Primary Completion Date
July 2022
Eligibility Criteria
Inclusion Criteria: - Toxic epidermal necrolysis with SCORTEN 1 to 5 at admission Exclusion Criteria: - Toxic epidermal necrolysis with SCORTEN 6 or 7 at admission - Hypercoagulable state - Cardiac or peripheral arterial disease - Active malignancy - Myelodysplastic syndrome or hematological malignancy - Fructose intolerance - Pregnancy - Patient refusal
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, , [email protected]
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02739295
Organization ID
L002
Responsible Party
Principal Investigator
Study Sponsor
University of Liege
Study Sponsor
, ,
Verification Date
November 2020