Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Ubicaciones

GSK Investigational Site

Villa Sarmiento-Haedo, Buenos Aires, Argentina

GSK Investigational Site

Córdoba, Córdoba Province, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad de Buenos Aires, Argentina

GSK Investigational Site

Moron-Provincia de Buenos Aires, Argentina

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Intravenous GR270773- Phospholipid Emulsion

Placebo

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores