Severe Bullous Drug Eruption and Filgrastim (GNET)
Rare Diseases, Toxic Epidermal Necrolyses
About this trial
This is an interventional treatment trial for Rare Diseases focused on measuring Toxic Epidermal Necrolysis (TEN), Stevens-Johnson syndrome (SJS), Lyell's syndrome, Ganulocyte-Colony Stimulating Factor (G-CSF), Filgrastim, Randomized controlled trial (RCT)
Eligibility Criteria
Inclusion Criteria:
- Patient aged of 6 years old or more, presenting SJS/TEN, drug or infectious origin proofed and very strongly suspected (indirect certainty argument), confirmed by evaluator.
- SJS or TEN evolving since less than 7 days with a progression of the detachment or the eruption observed dating less than 48 hours.
- Patient and/or have right able to understand the objectives of the trial and having given their written consent to participate (parents for minors, have right for patients in immediate life-saving emergency).
- Patient registered with a social security scheme or benefiting from a similar scheme.
- Pregnancy test beta HCG negative for women of childbearing age
Exclusion Criteria:
- Patient weighing less than 20kg
- Chronic myeloid pathology such as myeloid leukemia or AML (acute myeloid leukemia)
- Thrombophilia or thrombotic pathology in progress
- PNN (polymorphonuclear neutrophils) > 50.000 on the CBC (Complete Blood Count) during the inclusion visit
- Patient who received cyclosporine, anti-TNFalpha or intravenous immunoglobulins or lithium in the month prior the inclusion
- Pregnant or breastfeeding woman
- Patient under protective measure (safeguard measure, curatorship, guardianship) or deprived of liberty
- Patient in exclusion period after participation at other interventional clinical trial
- Known hypersensitivity to the active substance (FILGRASTIM) or to the one of the excipients (glutamine acid, sorbitol E420, Polysorbate 80)
- Patient presenting a known glucose intolerance or hereditary fructose intolerance
- Patient with a traumatic brain injury less than 24 hours
- Patient admitted with septic shock
Sites / Locations
- Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de LyonRecruiting
- Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de LyonRecruiting
- Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
FILGRASTIM
PLACEBO
Standard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + ZARZIO@ (30 MU/0,5mL and/or 48 MU/0,5mL - solution of 20 ml diluted in GLUCOSE 5%) administrated by IV or subcutaneous route over a period of 5 consecutive days (1 injection per day during 30 minutes)
Standard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + 20 ml GLUCOSE 5% administrated by IV route over a period of 5 consecutive days (1 injection per day during 30 minutes)