Subjects with Sepsis Induced Cardiovascular and Respiratory Failure
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-242
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigatio
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality | — |
Outcome results
None listed