Severe Sepsis
Conditions
Interventions
Product Name: Eritoran
Product Code: E5564
Pharmaceutical Form: Powder and solvent for solution for infusion
Sponsors
Eisai Limited
Eisai Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female subjects, age from gestational age greater than or equal to 38 weeks to less than 18 years with confirmed early-onset sepsis, as defined in the protocol - Must be a reasonable likelihood that the study drug adminstration can begin within 24 hours of the onset of sepsis-induced cardiovascular or respiratory organ dysfunction, whichever occurs first Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects with either sepsis-induced cardiovascular or respiratory organ dysfunction for greater than 24 hours before likely start time of study drug administration - Subjects who experienced an episode of sepsis-induced organ dysfunction (cardiovascular or respiratory) within the prior 45 days - Subjects whose death appears imminent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To evaluate the safety and tolerability of eritoran in pediatric subjects with severe sepsis - To determine the effects of eritoran on the following parameters in pediatric subjects with severe sepsis: - 28-day all cause mortality - duration of intensive care unit (ICU) and total hospital stay within 28 days - time to resolution of organ dysfunction ;Main Objective: - To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of eritoran in pediatric subjects with severe sepsis.; Primary end point(s): - PK endpoint is plasma endotoxin levels as measured by HPLC - PD endpoint is ability to block endotoxin activation by LPS in an ex vivo assay | — |
Countries
United Kingdom
Outcome results
None listed