Stevens - Johnson Syndrome
Conditions
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.
Interventions
DRUGrecombinant granulocyte - colony stimulating factor
DRUGNaCl 0.9%
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for healing | From date of randomization until the date of complete healing, assessed up to 30 days. | Time for complete cutaneous healing, considered as healing of 90% of the body surface area |
| Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) | At admission and at day 5 | Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) |
| Biological data: Neutrophilic count | Every day during the 14th first days | Neutrophilic count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological data: WBC count | 3 months after discharge | WBC count |
| Biological data: WBC formula | 3 months after discharge | WBC formula |
Countries
Belgium
Outcome results
None listed