Severe Bullous Drug Eruption and Filgrastim

Launched by HOSPICES CIVILS DE LYON · Nov 25, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a potential treatment for a severe skin condition called toxic epidermal necrolysis (TEN), which can occur as a serious allergic reaction to medications. The trial is testing a medication called filgrastim, which is designed to help heal the skin and improve the immune response in patients suffering from this condition. TEN can cause painful skin blisters and peeling, similar to severe burns, and has a high risk of serious complications, including infections and long-term health issues.

To participate in this trial, patients must be at least 6 years old and have been diagnosed with TEN or a related condition called Stevens-Johnson syndrome. They should show signs of the illness for less than a week, and their symptoms must have worsened recently. Participants will receive treatment and will be closely monitored by healthcare professionals. This study hopes to provide evidence that filgrastim can improve recovery from these serious conditions and reduce long-term health problems. If you or someone you know is interested in participating, it’s important to discuss it with a healthcare provider for more details.

Gender

ALL

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/mm3 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 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