A Multicenter, Open-label, Sequential, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Efficacy or Eritoran in Descending Age Groups of Pediatric Subjects with Severe Sepsis
- Conditions
- Severe Sepsis
- Registration Number
- EUCTR2010-020204-30-GB
- Lead Sponsor
- Eisai Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Secondary Objective: - To evaluate the safety and tolerability of eritoran in pediatric subjects with severe sepsis<br> - To determine the effects of eritoran on the following parameters in pediatric subjects with severe sepsis:<br> - 28-day all cause mortality<br> - duration of intensive care unit (ICU) and total hospital stay within 28 days<br> - time to resolution of organ dysfunction<br> ;Main Objective: - To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of eritoran in pediatric subjects with severe sepsis.;<br> Primary end point(s): - PK endpoint is plasma endotoxin levels as measured by HPLC<br> - PD endpoint is ability to block endotoxin activation by LPS in an ex vivo assay<br>
- Secondary Outcome Measures
Name Time Method