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A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis Clinical research trials and A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including 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 Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis clinical trial. Participants oftentimes recieve the finest healthcare available for their A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.

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

3. Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-related Bloodstream Infections

4. The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients with Severe Sepsis

5. Prophylactic Heparin during Xigris [Drotrecogin Alfa (Activated)] Treatment of High-Risk Severe Sepsis

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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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