Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)

Phase 1

Conditions: yell syndrome, Stevens Johnson syndrome
MedDRA version: 20.0Level: LLTClassification code: 10025166Term: Lyell syndrome Class: 10040785
MedDRA version: 20.1Level: LLTClassification code: 10042030Term: Stevens Johnson syndrome Class: 10040785
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: CTIS2024-515275-35-00

Lead Sponsor: Hospices Civils De Lyon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

Patient 6 years of age and older, presenting with SJS or NET of proven or very strongly suspected (indirect argument of certainty) drug or infectious origin, confirmed by the evaluator, SJS or NET evolving for less than 7 days and with progression of the detachment or rash observed within 48 hours, Patient and/or guardians capable of understanding the objectives of the trial and having given written consent to participate (parents for minors, guardians for patients in immediate life-threatening situations), Patient registered with a social security scheme or benefiting from a similar scheme, Negative beta-HCG pregnancy test for women of childbearing age

Exclusion Criteria

Patients weighing less than 20 kg, Known hypersensitivity to the active substance (FILGRASTIM) or to the one of the excipients (glutamine acid, sorbitol E420, Polysorbate 80), Patients with known glucose intolerance or hereditary fructose intolerance, Patient with a traumatic brain injury less than 24 hours, Patients in septic shock, Chronic myeloid disease such as myeloid leukemia or AML, Thrombophilia or current thrombosis pathology, PNN (polymorphonuclear neutrophils) > 50.000 on the CBC (Complete Blood Count) during the inclusion visit, Administration of G-CSF or GM-CSF within 5 days of inclusion, Patient who received cyclosporine, anti-TNFalpha or intravenous immunoglobulins or lithium in the month prior the inclusion, Pregnant or breast-feeding women, Patient under protective measure (safeguard measure, curatorship, guardianship) or deprived of liberty, Patient in exclusion period after participation at other interventional clinical trial