The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

Lilly

Status and phase: Completed; Phase 3

Conditions: Sepsis

Treatments: Drug: Drotrecogin alfa (activated); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568737

F1K-MC-EVCM

6669

Details and patient eligibility

About

Adult Patients with Severe Sepsis

Full description

Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score <25 or single organ dysfunction).

Enrollment: 2,640 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.

Exclusion criteria

• Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
• Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
• Platelet count less than 30,000/mm3.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,640 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Treatment:

Drug: Drotrecogin alfa (activated)

2

Placebo Comparator group

Description:

0.9% sodium chloride

Treatment:

Drug: Placebo