Status:
COMPLETED
GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2007
Estimated Enrollment :
1415 Patients enrolled
Trial Details
Trial ID
NCT00089986
Start Date
September 1 2004
End Date
April 15 2007
Last Update
August 21 2017
Active Locations (390)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Phoenix, Arizona, United States, 85006
3
GSK Investigational Site
Tucson, Arizona, United States, 85711
4
GSK Investigational Site
Tucson, Arizona, United States, 85724