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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G-CSF | Experimental | An intravenous dose of 5 microg/kg of G-CSF (Neupogen) will be administered daily, from admission (day 0) to day 4. |
|
| Placebo | Placebo Comparator | An intravenous dose of 5 ml of NaCl 0.9% will be administered daily, from admission (day 0) to day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant granulocyte - colony stimulating factor | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time for healing | Time for complete cutaneous healing, considered as healing of 90% of the body surface area | From date of randomization until the date of complete healing, assessed up to 30 days. |
| Immunohistology: Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) | Changes in immunohistologic typing (MAC 387, CD15, CD68, CD45Ro, fact XIIIa) | At admission and at day 5 |
| Biological data: Neutrophilic count | Neutrophilic count | Every day during the 14th first days |
| Measure | Description | Time Frame |
|---|---|---|
| Biological data: WBC count | WBC count | 3 months after discharge |
| Biological data: WBC formula | WBC formula | 3 months after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burn Centre of the University Hospital of Liège | Liège | 4000 | Belgium | |||
| IMTR Burn Centre |
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| ID | Term |
|---|---|
| D013262 | Stevens-Johnson Syndrome |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003875 | Drug Eruptions |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| NaCl 0.9% |
| Drug |
|
| Loverval |
| Belgium |
| D003872 |
| Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004892 | Erythema Multiforme |
| D004890 | Erythema |
| D012872 | Skin Diseases, Vesiculobullous |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D004342 | Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |