A randomized, Double-Blind, Placebo-controlled Study of the Efficacy and Safety of TAK-242 Versus Placebo in Subjects With Sepsis Induced Cardiovascular and Respiratory Failure
- Conditions
- Subjects with Sepsis Induced Cardiovascular and Respiratory Failure
- Registration Number
- JPRN-jRCT2080220566
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 2500
Main Inclusion Criteria
1. Subject is aged 18 years or older, with bacterial or infection for which he/she is receiving parenteral antimicrobial therapy.
2. Subject has septic shock diagnosed and developed respiratory failure within 36 hours prior to study drug administration, and meets at least 3 of the 4 SIRS criteria.
Main Exclusion Criteria
1. Subject is known to be immunocompromised, and is currently receiving immunosuppressive therapy or a cancer related chemotherapeutic agent.
2. Prior to the onset of sepsis, the subject would not otherwise have been expected to survive 28 days or to complete a functional recovery due to a pre-existing unstable medical condition.
3. Subject has acute third degree burns involving more than 30% of body surface area.
4. Subject, family, or physician is not committed to full aggressive management.
5. Subject has known hypersensitivity to sulphonamides, or is allergic to eggs, egg products or soybeans.
6. Subject has a documented history of chronic heart failure as defined by NYHA functional classification III or IV.
7. Subject has severe end stage chronic respiratory failure or chronic end stage hepatic failure.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method