A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients with Severe Sepsis and Multiple Organ Dysfunction - RESPOND

• Conditions: Patients with severe sepsis and multiple organ dysfunction; MedDRA version: 9.1Level: HLTClassification code 10040054Term: Sepsis, bacteraemia and viraemia

• Registration Number: EUCTR2006-002112-99-IT
• Lead Sponsor: Eli Lilly UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

Adult patients (>=18 years old) with severe sepsis and multiple organ dysfunction
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Have documented multiple organ dysfunction for greater than 24 hours prior to the start of study drug or the first documented sepsis-induced organ dysfunction occurred greater than 36 hours prior to the start of study drug. [Weigh less than 30 kg or greater than 135 kg. Have a platelet count <30,000/mm3.Patients with active internal bleeding or at increased risk for bleeding. Have a concurrent need for any of the following medications during the drotrecogin alfa (activated) infusion. Are not expected to survive 28 days given their preexisting uncorrectable medical condition. HIV/AIDS patients with known end-stage processes (for example, progressive multi-focal leukoencephalopathy [PML], mycobacterium avium complex [MAC], Epstein-Barr virus [EBV], or lymphoma, or a known CD4 count <50 cells/mm3). Are moribund and death is perceived to be imminent (within 24 hours). re not committed to aggressive management of the patient. For example, the patient?s family or primary physician is unwilling to allow red blood cell transfusions, or an advanced directive to withhold life-sustaining treatment, with the exception of cardiopulmonary resuscitation, is present. Have received treatment within the last 30 days with drotrecogin alfa (activated). Have received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indication at the time of study entry. Are pregnant or lactating and the milk is to be ingested by the newborn. Fail to give written informed consent or the patient?s legal representative fails to give written informed consent. Are investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. Are Lilly employees.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified