42
Participants
Start Date
May 13, 2022
Primary Completion Date
May 18, 2025
Study Completion Date
May 13, 2026
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)"
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)"
RECRUITING
Département d'Anesthésie-Réanimation , Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon
RECRUITING
Reference center for toxic bullous dermatoses and severe drug eruptions, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon
RECRUITING
Service de Médecine Interne, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon
Hospices Civils de Lyon
OTHER