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Clinical Trials/NCT00034476
NCT00034476
Completed
Phase 1

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

Eli Lilly and Company0 sites466 target enrollmentOctober 2001
ConditionsSepsis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Sepsis
Sponsor
Eli Lilly and Company
Enrollment
466
Status
Completed
Last Updated
19 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
October 2002
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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