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



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

For Condition: Sepsis
Status: Terminated
Sponsor(s): Eli Lilly and Company ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 466

Location and Contact Information:


Additional Information:
Study ID Numbers:
  1641; 
Study Start Date: October 2001
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034476

Other Sepsis Studies:
1. A Prospective, Randomized, Phase III Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Chemotherapy with GM-CSF (Granulocyte-Macrophage Colony-Stimulating Factor) Versus PIXY 321 in Advanced Breast Cancer

2. Effects of Endotoxin in Normal Human Volunteers

3. Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

4. Phase I Study of Vasoactive Intestinal Peptide in Patients with Acute Respiratory Distress Syndrome and Sepsis

5. Assessment of pleconaril for treatment of enteroviral sepsis syndrome in neonates

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

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