NCT00563134

A Randomised Trial on the Saftely and Efficacy of GR270774 in the Treatment of Gram-negative Sepsis in Adult

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: Hospital Authority, Hong Kong · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Sepsis sometimes occurs in people who have a serious infection. It is caused by toxic substances (toxins) from bacteria and other germs entering your bloodstream. Most people with sepsis will recover with routine medical care before the illness gets more serious. However, in some people, sepsis does become more serious. This severe sepsis can cause damage to internal organs (such as your heart, lungs, kidneys, and liver) and can be life threatening. Special natural fats, (called 'lipoproteins') in our blood are thought to help protect us from the toxins produced by bacteria during sepsis. Levels of these lipoproteins are often low in people with sepsis and this may make it more difficult to recover from the disease. GR270773 is a new drug that has been developed to help the lipoproteins in protecting the body against toxins. GR270773 is made from purified fats and oils from the soyabean and does not contain cholesterol. This research study will test the safety (side effects) of GR270773 and whether or not it is effective in preventing complications in people with severe sepsis.

Conditions

• Gram-Negative Bacterial Infections
• Sepsis

Interventions

Type	Name	Description
DRUG	GR270774

Timeline

• Start date: 2005-10-01
• Completion: 2006-12-01
• First posted: 2007-11-26
• Last updated: 2010-07-07

Locations

1 site across 1 country: China