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OpenTrials
Completed

NCT Number: NCT00568893

An Open Label Study of Severe Sepsis in Adults

This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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., Antwerp, Belgium

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About this study

To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:
  • Must be 18 years.
  • Suspected or proven infection
  • Have or have had two or more sepsis-induced organ failures sepsis

Exclusion criteria

  • Patients will be excluded from entry in this study for any of the following reasons:
  • Documented first organ dysfunction greater than 48-hours prior to start of study drug.
  • Patients greater than 135 kg in weight.
  • Patients with a platelet count less than 30,000/mm3
  • Active internal bleeding or at increased risk for bleeding

Treatment and study plan

Drotrecogin Alfa (Activated)

Drug

Other names: LY203638, Xigris

Primary outcomes

  1. Safety Data

    Time frame: 9 Months

Secondary outcomes

  1. All cause mortality data.

    Time frame: 9 Months

  2. To determine the final disposition of sepsis patients treated with drotrecogin alfa (activated)(that is, patient location at discharge from study hospital or 90 days).

    Time frame: 9 Months

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol

Important dates

Study start
2003
Study completion
2003
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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