Efficacy & Safety of Resatorvid in Adults With Severe Sepsis

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the optimal dose of Resatorvid for reducing 28-day all-cause mortality in subjects with severe sepsis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

Inclusion Criteria:

• Has clinical evidence of infection defined as the presence of a known or probable source of infection requiring the initiation of parenteral antimicrobial therapy.

• Must meet at least 3 of the following 4 criteria for SIRS:

• A core temperature greater than 38°C or less than 36°C.

• A heart rate greater than 90 beats per minute.

• A respiratory rate greater than 20 breaths/min or partial pressure of carbon dioxide in arterial blood less than 32 mm Hg or mechanical ventilation for an acute process.

• A total white blood cell absolute count greater than 12,000 cells/mm3 or less than 4,000 cells/mm3, or a white blood cell differential count that showed greater than 10% immature (band) forms.

• Must have sepsis with shock and/or respiratory failure.

Exclusion Criteria

• If female, the subject is pregnant, nursing and the milk is intended to be ingested by the infant, or the participant plans to become pregnant, or nurse and the milk is intended to be ingested by the infant.

• Is receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer-related chemotherapy.

• Has a granulocyte count of less than 1000/mm3 except if the decreased count was believed to be due to sepsis.

• Has documented or suspected acute myocardial infarction within the last 6 weeks prior to Pretreatment Period.

• Has a documented history of moderate to severe chronic heart failure as defined by New York Heart Association Functional Classification III or IV.

• Is known to be positive for human immunodeficiency virus with known CD4 count less than or equal to 50/mm3 or had known end-stage processes.

• Has a known history of glucose-6-phosphate dehydrogenase deficiency.

• Has a methemoglobin level greater than 5% at Pretreatment Period or had a known history of methemoglobinemia.

• Is moribund and death was considered imminent.

• Is classified as "Do Not Resuscitate", or "Do Not Treat", or the participant's family has not committed to aggressive management of the participant's condition.

• Is not expected to survive for 28 days and was not likely be given life support due to a pre-existing, uncorrectable medical condition.

• Has a known esophageal varices, chronic jaundice, cirrhosis, or chronic ascites.

• Is in a chronic vegetative state or has a similar long-term neurological condition.

• Has known portal hypertension or Child-Pugh hepatic impairment class C.

• Has acute third degree burns involving more than 30% of body surface within 120 hours prior to Pretreatment Period.

• Has known hypersensitivity to sulfonamides.

• Has known hypersensitivity to components of resatorvid.

• Has participated in any other investigational study (drug or device) and/or taken any investigational drug within 30 days or 5 half-lives of the drug.