Evaluating the Therapeutic Efficacy of Filgrastim in Severe Bullous Drug Eruptions (Lyell and Stevens-Johnson Syndromes)

Conditions

Lyell syndrome, Stevens Johnson syndrome

Brief summary

Comparison between the 2 groups of the proportion of patients with a halt in the progression of skin detachment at D5 (D0: initiation of treatment) defined by a detached and/or bullous surface and/or associated with a NIKOLSKY sign determined according to the stable burns table

Detailed description

Time to stop progression, Time to complete re-epidermalization, defined as disappearance of skin erosions AND return to normal skin, Overall survival at D30, Overall survival to D365, Number of hospital days corresponding to the length of hospitalization for the SJS/NET episode, Number per patient and nature of clinical or biological adverse events observed between D0 and D5 leading to premature discontinuation of filgrastim treatment, Total number per patient and nature of clinical or biological adverse events observed up to D365, Use of systemic corticosteroid therapy between D0 and D15, with a study of the nature, cumulative doses and indications for objective prescriptions. A comparison will be made between the 2 treatment groups., Presence of ophthalmological, stomatological/ORL, gastroenterological, gynecological, urological and psychiatric sequelae, Patient quality of life, Risk of developing post-traumatic stress disorder (PTSD)

Related papers

No related papers found yet.

Interventions

DRUGZarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe

DRUGGLUCOSE FRESENIUS 5 %

DRUGsolution pour perfusion

DRUGZarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Comparison between the 2 groups of the proportion of patients with a halt in the progression of skin detachment at D5 (D0: initiation of treatment) defined by a detached and/or bullous surface and/or associated with a NIKOLSKY sign determined according to the stable burns table	—

Secondary

Measure	Time frame
Time to stop progression, Time to complete re-epidermalization, defined as disappearance of skin erosions AND return to normal skin, Overall survival at D30, Overall survival to D365, Number of hospital days corresponding to the length of hospitalization for the SJS/NET episode, Number per patient and nature of clinical or biological adverse events observed between D0 and D5 leading to premature discontinuation of filgrastim treatment, Total number per patient and nature of clinical or biological adverse events observed up to D365, Use of systemic corticosteroid therapy between D0 and D15, with a study of the nature, cumulative doses and indications for objective prescriptions. A comparison will be made between the 2 treatment groups., Presence of ophthalmological, stomatological/ORL, gastroenterological, gynecological, urological and psychiatric sequelae, Patient quality of life, Risk of developing post-traumatic stress disorder (PTSD)	—

Measure

Time frame

Time to stop progression, Time to complete re-epidermalization, defined as disappearance of skin erosions AND return to normal skin, Overall survival at D30, Overall survival to D365, Number of hospital days corresponding to the length of hospitalization for the SJS/NET episode, Number per patient and nature of clinical or biological adverse events observed between D0 and D5 leading to premature discontinuation of filgrastim treatment, Total number per patient and nature of clinical or biological adverse events observed up to D365, Use of systemic corticosteroid therapy between D0 and D15, with a study of the nature, cumulative doses and indications for objective prescriptions. A comparison will be made between the 2 treatment groups., Presence of ophthalmological, stomatological/ORL, gastroenterological, gynecological, urological and psychiatric sequelae, Patient quality of life, Risk of developing post-traumatic stress disorder (PTSD)

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Countries

France

Outcome results

None listed