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Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)
EU CTIS ID: 2024-515275-35-00
What this study is testing
Compare, after 5 days of treatment, the cessation of disease progression in patients with SJS/NET between the experimental arm receiving filgrastim in addition to the reference symptomatic treatment (FILGRASTIM group) and the control arm receiving only the reference symptomatic treatment combined with placebo (CONTROL group).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.