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Completed

NCT Number: NCT00034476

A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.

The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.

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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 1 / Phase 2

Primary location

Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients must

  • show evidence of acute infection
  • meet specified time windows
  • be 18 years of age or older

Exclusion criteria

Patients must not

  • have low white blood cell count
  • have undergone certain organ transplants
  • be HIV positive
  • be pregnant or breast feeding
  • have severe underlying medical problems

Treatment and study plan

sPLA2 Inhibitor

Drug

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Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2001
Study completion
2002
First posted
Apr 30, 2002
Registry last updated
Jul 19, 2006

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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