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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00089986 |
The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.
Condition | Intervention | Phase |
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Sepsis |
Drug: Intravenous GR270773- Phospholipid Emulsion |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-Negative Severe Sepsis in Adults |
Enrollment: | 1890 |
Study Start Date: | September 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EMD20001 |
Study First Received: | August 18, 2004 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00089986 |
Health Authority: | United States: Food and Drug Administration; Canada: Canadian Institutes of Health Research; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
severe sepsis septic shock Gram-negative infection phospholipid emulsion |
Systemic Inflammatory Response Syndrome Sepsis Shock Shock, Septic Inflammation |
Pathologic Processes Infection |