GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
This study has been completed.
Information provided by (Responsible Party):
First received: August 18, 2004
Last updated: July 31, 2014
Last verified: November 2012
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.
Drug: Intravenous GR270773- Phospholipid Emulsion
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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
Primary Outcome Measures:
- 28-day all-cause mortality [ Time Frame: 28 Days ]
Secondary Outcome Measures:
- New onset organ failure in an organ not in failure at enrollment.Assess safety/tolerability by determining the incidence of adverse events in the GR270773 treatment groups versus placebo [ Time Frame: 28 Days ]
| Study Start Date:
Drug: Intravenous GR270773- Phospholipid Emulsion
Other Name: Intravenous GR270773- Phospholipid Emulsion
Other Name: Matched placebo infusion
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection.
- Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.
- Must be available and able to receive the first dose of study medication no more than 12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ failure and within 36 hours after the initiation of new parenteral antibacterial therapy for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis.
- 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/mcL or expected to decline to <500/mcL in the next 3 days).
- 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 baseline hemoglobin (measured after adequate volume resuscitation) <9.0 g/dL (5.59 mmol/L).
- 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 GR270773.
- Subject has been designated as 'not full support do not resuscitate' (DNR), or other equivalent status which prohibits the use of life supporting interventions (e.g., mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the treatment options available.
Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.
- Subject has preexisting severe liver disease such as cirrhosis, primary biliary cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.
- Subject is moribund (a state in which death is perceived to be imminent) or has a life expectancy of less than 3 months due to an underlying disease.
- Subject is currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid emulsions (e.g., INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00089986
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 18, 2004
||July 31, 2014
||Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Canadian Institutes of Health Research
United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on March 30, 2015