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Completed

NCT Number: NCT00568737

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

Adult Patients with Severe Sepsis

Completed

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Haedi, Buenos Aires, Argentina

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

Drotrecogin Alfa (activated)

Other names: LY203638, Xigris

Placebo

Drug

0.9% sodium chloride

Primary outcomes

  1. Efficacy

    Time frame: 20 months

Secondary outcomes

  1. Safety

    Time frame: 20 months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

Important dates

Study start
2002
Study completion
2005
First posted
Dec 6, 2007
Registry last updated
Dec 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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