Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

Lilly

Status and phase: Completed; Phase 2

Conditions: Severe Sepsis

Treatments: Drug: Drotrecogin alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00386425

10553 (Registry Identifier)

F1K-MC-EVDK (Other Identifier)

Details and patient eligibility

About

In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.

Enrollment: 486 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be 18 years or older
• Must have a suspected or proven infection
• Must have two or more sepsis-associated organ dysfunctions

Exclusion criteria

• Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
• Actual body weight less than 30 kg or more than 135 kg
• Platelet count less than 30,000/mm^3
• Active internal bleeding or at increased risk of bleeding
• Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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486 participants in 3 patient groups

Standard therapy

Experimental group

Description:

24 microgram/kilogram/hour (mcg/kg/hr) for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours

Treatment:

Drug: Drotrecogin alfa (activated)

Alternative therapy:moderate protein C deficiency

Experimental group

Description:

24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)

Treatment:

Drug: Drotrecogin alfa (activated)

Alternative therapy:severe protein C deficiency

Experimental group

Description:

24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for 48 to 144 hours (original protocol) or an additional 72 to 144 hours (amended protocol)

Treatment:

Drug: Drotrecogin alfa (activated)