Efficacy of IntraVenous ImmunoGlobulins in Toxic Shock Syndromes: a Paediatric Pilot Study

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 8, 2015

Primary Completion Date

April 19, 2019

Study Completion Date

April 19, 2019

Conditions
Toxic Shock Syndrome
Interventions
DRUG

Intravenous human immunoglobulin

Single administration of IVIG 2 g/kg within the 12 hours following PICU admission (or following the manifestation of the first signs of shock). The bottles of IVIG used will contain 10 g of proteins in 100 ml of solution. Thus, to reach a concentration of 2 g/kg, will be administered 1 bottle per 5 kg of body weight (with a maximum of 14 bottles for 70 kg patients and over).

DRUG

Albumin

Single administration of albumin 4% within the 12 hours following PICU admission (or following the manifestation of the first signs of shock). The solution will be given at the same volume as IVIG (that is: 1 bottle / 5 kg of body weight).

Trial Locations (1)

69677

Hôpital Femme Mère Enfant, Bron

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02219165 - Efficacy of IntraVenous ImmunoGlobulins in Toxic Shock Syndromes: a Paediatric Pilot Study | Biotech Hunter | Biotech Hunter