CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,415 enrolled
Drug / intervention
Intravenous GR270773- Phospholipid Emulsion +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Receiving parenteral antibiotic therapy for suspected or confirmed Gram-negative infection
  • ✓At least one new hypoperfusion abnormality or new onset organ failure from current septic episode
  • ✓First dose within 12 hours of hypoperfusion/organ failure confirmation AND within 36 hours of antibiotic initiation
Key exclusion· 11
  • ✕Unlikely to remain hospitalized for minimum 72 hours post-enrollment
  • ✕Neutropenia: ANC <500/mcL or expected to decline to <500/mcL within 3 days
  • ✕Known active hemolytic disease, immune hemolytic anemias, or hemoglobinopathies (sickle cell, thalassemia major)
  • ✕Bone marrow disorder causing inadequate red cell production (aplastic anemia, myelodysplasia)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00089986
NCT00089986Phase 2Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Aug 23, 2004·Updated Aug 21, 2017

In Brief

A Phase 2 clinical trial evaluating Intravenous GR270773- Phospholipid Emulsion and Placebo for Sepsis. Completed, enrolled 1,415 participants across 390 sites in 34 countries.

Detailed 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-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Latvia, Malaysia, Netherlands, New Zealand, Portugal, Puerto Rico, Romania, Russia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 23, 2004
Enrollment StartSep 1, 2004
Primary CompletionApr 1, 2007
Study CompletionApr 15, 2007
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 21.9 years ago

Interventions

Intravenous GR270773- Phospholipid Emulsiondrug

Placeboother