Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia

PHASE4RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

October 24, 2024

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

Conditions
SepsisNeuroinflammatory ResponseImmunosuppresionEndotoxemiaAnakinraDexamethasoneTocilizumab
Interventions
DRUG

Dexamethasone

Dexamethasone 6mg in 10mL NaCl 0.9% i.v. bolus + 100mL NaCl 0.9% placebo infusion in 1 hour on the first LPS challenge.

DRUG

Tocilizumab

Tocilizumab 600mg in 100mL NaCl 0.9% i.v. in 1 hour + a bolus of 10mL NaCl 0.9% placebo infusion on the first LPS challenge.

DRUG

Anakinra

Anakinra 200mg in 100mL NaCl 0.9% i.v. in 1 hour + a bolus of 10mL NaCl 0.9% placebo infusion on the first LPS challenge.

DRUG

Placebo

Bolus of 10mL NaCl 0.9% placebo + 100mL NaCl 0.9% placebo infusion in 1 hour on the first LPS challenge.

BIOLOGICAL

LPS

This is a non-investigational product. It is used as challenge agent to achieve a controlled inflammatory state.

Trial Locations (1)

6500 HB

RECRUITING

Intensive Care Medicine, Radboud University Nijmegen Medical Centre, Nijmegen

All Listed Sponsors
lead

Radboud University Medical Center

OTHER

NCT06624436 - Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia | Biotech Hunter | Biotech Hunter