GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089986
First received: August 18, 2004
Last updated: November 21, 2012
Last verified: September 2012
  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
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Intervention Details:
    Drug: Intravenous GR270773- Phospholipid Emulsion
    Other Name: Intravenous GR270773- Phospholipid Emulsion
    Other: Placebo
    Other Name: Matched placebo infusion
  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

  Show 366 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00089986     History of Changes
Other Study ID Numbers: EMD20001
Study First Received: August 18, 2004
Last Updated: November 21, 2012
Health Authority: 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:
septic shock
phospholipid emulsion
Gram-negative infection
severe sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014