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

Hospital Authority, Hong Kong1 site in 1 country1,800 target enrollmentOctober 2005

ConditionsGram-Negative Bacterial Infections Sepsis

DrugsGR270774

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gram-Negative Bacterial Infections
Sponsor: Hospital Authority, Hong Kong
Enrollment: 1800
Locations: 1
Primary Endpoint: Mortality
Status: Suspended
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

December 2006

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Authority, Hong Kong

Eligibility Criteria

Inclusion Criteria

•Subject is 18 years of age or over.
•Subject has one of the following bacterial infections (as defined in Section 14.5) and a suspected or confirmed Gram-negative etiology:
•Confirmed Gram-negative bacteremia (Gram-negative pathogen must be isolated from blood culture prior to study entry)
•Intra-abdominal infection
•Nosocomial pneumonia (Evidence of Gram-negative organism from histology or by direct stain of a respiratory specimen required prior to study entry)
•Pyelonephritis
•Subject is receiving new parenteral antibacterial treatment for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis. The subject must receive study drug within 36 hours of commencing treatment with this new antibacterial agent.
•Note: Changes in antibiotic coverage made to treat the infection causing the current episode of sepsis or needed to treat a deteriorating subject in whom previous antibiotic coverage was deemed inadequate will be viewed as a new antibiotic.
•Subject has signs of new-onset severe sepsis as evidenced by at least ONE of the following hypoperfusion abnormalities OR organ failures caused by the current episode of sepsis. Subject must receive study medication within 12 hours from onset of the first sepsis-related hypoperfusion abnormality or organ failure:
•Persistent oliguria (urine output \<0.5 mL/kg/hr for at least two hours after adequate volume resuscitation (ie, \>=2 L isotonic crystalloid or appropriate colloid to achieve the same effect)) Note: This criterion does not apply to subjects with chronic renal insufficiency/failure.

Exclusion Criteria

•Subject is currently participating in or has participated in an investigational drug or medical device trial within 30 days or five half-lives, which ever is longer, prior to enrollment in this study.
•Subject is unlikely to remain in hospital for a minimum of three days (72 hours) following enrollment.
•Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count \<500/µL or expected to decline to \<500/µL in the next 3 days).
•Subject is known or believed to suffer from hereditary spherocytosis or S.E. Asian elliptocytosis.
•Subject has known active hemolytic disease; immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major).
•Subject has a known bone marrow disorder of inadequate red cell production (eg, aplastic anemia, myelodysplasia).
•Subject is at increased risk of complications from GR270773-related hemolysis due to the inability to increase cardiac function sufficiently to meet the demands for oxygen delivery.
•Subject has a hemoglobin level at screening \<9.0 g/dL (5.59 mmol/L). This hemoglobin assessment should be based on the most recent available data in the subject's medical record at the time of screening and is not used in the assessment of the hemoglobin stopping rule described in Section 6.2.
•Subject is currently being treated with Xigris (Drotrecogin alfa (activated)) or its use is considered imminent (ie, a decision to treat with Xigris has been made).
•Subject has a history of allergic reaction to eggs (or egg products), soybeans, Intralipid, or any component of GR