Treatment for severe skin reactions caused by drugs
Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)
This study is testing if a drug called Filgrastim can help people aged 6 and older who have serious skin reactions from medications, like Toxic Epidermal Necrolysis and Stevens-Johnson syndrome, feel better compared to those getting a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 3 sites (Lyon and 2 other locations) |
| Trial ID | NCT04651439 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Filgrastim, a granulocyte-colony stimulating factor, in treating severe bullous drug eruptions such as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson syndrome (SJS). These conditions are characterized by extensive skin peeling and high mortality rates due to complications. The trial aims to assess the efficacy of Filgrastim compared to a placebo in patients who have recently developed these severe skin reactions. Participants must be aged 6 years or older and meet specific inclusion criteria related to the onset and cause of their condition.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 years and older with a confirmed diagnosis of SJS or TEN that has progressed within the last 7 days.
Not a fit: Patients with chronic myeloid pathologies or those weighing less than 20 kg are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality and morbidity associated with severe drug eruptions.
How similar studies have performed: While there is limited data on the use of Filgrastim for these specific conditions, the approach of targeting immune response in severe drug reactions is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon and 2 other locations
- Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de Lyon — Lyon, France (Recruiting)
- Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de Lyon — Lyon, France (Recruiting)
- Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Benoit BEN SAID, MD
- Email: benoit.ben-said@chu-lyon.fr
- Phone: 472 117 211
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.