Actively Recruiting
Severe Bullous Drug Eruption and Filgrastim
Led by Hospices Civils de Lyon · Updated on 2024-05-08
42
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Toxic epidermal necrolysis (TEN) including Stevens Johnson (SJS) and Lyell syndromes represent the most severe drug eruptions. It is an allergic disorder caused by cytotoxic T lymphocytes, specific of drugs, responsible for the destruction of keratinocytes by apoptosis. Regulatory T cell (CD25 high CD4+), normally responsible for controlling the activation of cytotoxic T lymphocytes, have altered function. Despite the progress made in the pathophysiological understanding of TEN, there is currently no effective treatment. The main symptom is bullous and skin peeling \> 10% giving the appearance of great burns. The death rate is estimated between 30 and 40% due to visceral inflammatory injuries and bacterial superinfection. The risk of mortality is estimated during the initial treatment by calculating the SCORTEN (mortality\>10% if SCORTEN\>2, mortality\>90% if SCORTEN\>5). The morbidity is also very important (92% at 1 year), especially ophthalmologic with high risk of blindness... The therapeutic potential of G-CSF (Granulocyte-Colony Stimulating Factor) in TEN is supported by several observations. The G-CSF promotes skin healing. This has been shown in human burns, with a significant reduction in healing time under G-CSF. The mechanisms associate the growth factor effect on keratinocytes, macrophages stimulation and metalloprotease activity allowing tissue remodeling limiting sequels onset. Otherwise, healing altered in deficient G-CSF mice is corrected by the growth factor injection. The G-CSF is an immunomodulator whose activities appear to justify use in TEN : * Polarization of immune response to Th2 non-cytotoxic (anti Th1), * Preferential differentiation of naive LT (T lymphocytes) in regulator LT (CD25 high CD4+) and mobilization of regulator LT of the spinal cord to altered tissues. The G-CSF was used in a few cases of TEN with great efficacy. No data is available concerning sequels of SJS/TEN in treated patients. This clinical trial program, by providing proof of the efficacy of filgrastim in SJS/TEN, should allow progress in care of this serious toxics diseases. In the future, it could thus reduce the significant morbidity of these syndromes with a high rate of sequelae.
CONDITIONS
Official Title
Severe Bullous Drug Eruption and Filgrastim
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 6 years old or older
- Confirmed or strongly suspected Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis of drug or infectious origin
- Symptoms have been present less than 7 days with progression of skin detachment or eruption within the last 48 hours
- Participant or legal guardian understands the trial and has given written consent
- Participant is registered with a social security or similar scheme
- Negative pregnancy test for women of childbearing age
You will not qualify if you...
- Participant weighs less than 20 kg
- Chronic myeloid diseases such as myeloid leukemia or acute myeloid leukemia
- Active thrombophilia or thrombotic disease
- Polymorphonuclear neutrophils count over 50,000/mm3 at inclusion
- Received G-CSF or GM-CSF within 5 days before inclusion
- Received cyclosporine, anti-TNF alpha, intravenous immunoglobulins, or lithium within 1 month before inclusion
- Pregnant or breastfeeding
- Under protective legal measures or deprived of liberty
- Participating in exclusion period after another interventional trial
- Known allergy to filgrastim or its components
- Known glucose or hereditary fructose intolerance
- Traumatic brain injury within 24 hours
- Admitted with septic shock
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, France, 69437
Actively Recruiting
2
Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de Lyon
Lyon, France, 69437
Actively Recruiting
3
Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, France, 69437
Actively Recruiting
Research Team
B
Benoit BEN SAID, MD
CONTACT
L
Laurent MAGAUD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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