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Clinical Trial Finder

Severe Bullous Drug Eruption and Filgrastim

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 6 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04651439
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hospices Civils de Lyon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rare Diseases, Toxic Epidermal Necrolyses
Arms & Interventions

Arms

Experimental: FILGRASTIM

Standard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + ZARZIO@ (30 MU/0,5mL and/or 48 MU/0,5mL - solution of 20 ml diluted in GLUCOSE 5%) administrated by IV or subcutaneous route over a period of 5 consecutive days (1 injection per day during 30 minutes)

Placebo Comparator: PLACEBO

Standard symptomatic treatment of the SJS/NET (until the reepidermization of the patient) + 20 ml GLUCOSE 5% administrated by IV route over a period of 5 consecutive days (1 injection per day during 30 minutes)

Interventions

Drug: - Filgrastim

Injection of ZARZIO 30 MU/0,5mL and/or ZARZIO 48 MU/0,5mL, over a period of 5 consecutive days (1 injection per day during 30 minutes - - day 1 : set up standard treatment). The filgrastim solution will be diluted in 20 mL of 5% Glucose. The dose of ZARZIO administrated depends of the patient's weight : - 20 to < 30kg = 0,3 mL of ZARZIO 48 MU/0,5mL (subcutaneous route) - 30 to < 60kg = 0,5 mL of ZARZIO 30 MU/0,5mL (by IV) - 60 to < 90kg = 0,5 mL of ZARZIO 48 MU/0,5mL (by IV) - 90 to < 120kg = 2x0,5 mL of ZARZIO 30 MU/0,5mL (by IV) - 120 to 150kg = 0,5 mL of ZARZIO 30 MU/0,5mL + 0,5 mL of ZARZIO 48 MU/0,5mL (by IV) - > 150kg = 2x0,5 mL of ZARZIO 48 MU/0,5mL (by IV)

Drug: - Placebo

Injection of 20 mL of Glucose 5% solution over a period of 5 consecutive days (1 injection per day during 30 minutes - day 1 : set up standard treatment). The dose given is equivalent to that used for filgrastim : - 20 to < 30kg = placebo not available because the injection must be done subcutaneously so the blind cannot be respected. - 30 to < 60kg = 20mL of Glucose 5% solution (by IV) - 60 to < 90kg = 20mL of Glucose 5% solution (by IV) - 90 to < 120kg = 20mL of Glucose 5% solution (by IV) - 120 to 150kg = 20mL of Glucose 5% solution (by IV) - > 150kg = 20mL of Glucose 5% solution (by IV)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

LYON cedex 03, France

Status

Recruiting

Address

Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de Lyon

LYON cedex 03, , 69437

Site Contact

Anne-Claire LUKASZEWICZ, MD

[email protected]

472 117 211

Lyon, France

Status

Recruiting

Address

Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de Lyon

Lyon, , 69437

Site Contact

Benoit BEN SAID, MD

[email protected]

472 117 211 #+33

Lyon, France

Status

Recruiting

Address

Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, , 69437

Site Contact

Solène POUTREL, MD

[email protected]

472 117 211

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