Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purposes of this study are to determine:

1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).

2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.

3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Drotrecogin alfa activated; Protein C

Criteria

Inclusion Criteria:

• Suspected or proven acute infection.

• Abnormally high or low core body temperature

• Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.

• Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.

Exclusion Criteria:

• Patients at increased risk of bleeding.

• Patients at high risk for an intracranial bleed.

• Patients who have undergone a bone marrow transplant.

• Patients with end-stage renal disease.

• Patients whose family or primary care physician is unwilling to allow transfusion of blood products.