Clinical trial NCT00089986 (phase 2, status: completed)
Conditions: sepsis
ICD codes: A02.1, A22.7, A26.7, A32.7, A42.7, A54.86, B37.7
Drugs: intravenous gr270773- phospholipid emulsion
SMILES: CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility 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.