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GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
This study has been terminated.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00089986
  Purpose

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.


Condition Intervention Phase
Sepsis
Drug: Intravenous GR270773- Phospholipid Emulsion
Phase II

MedlinePlus related topics: Sepsis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Further study details as provided by GlaxoSmithKline:

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 ]

Enrollment: 1890
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089986

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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: EMD20001
Study First Received: August 18, 2004
Last Updated: October 16, 2008
ClinicalTrials.gov Identifier: NCT00089986  
Health Authority: United States: Food and Drug Administration;   Canada: Canadian Institutes of Health Research;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by GlaxoSmithKline:
severe sepsis
septic shock
Gram-negative infection
phospholipid emulsion

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009