Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

≥ 18 years
Suspected or proven bacterial infection
Receiving positive pressure ventilation through an endotracheal tube

Have ALI/ARDS, defined as having all of the following:

bilateral infiltrates consistent with pulmonary edema
Hypoxemia
no clinical evidence of left atrial hypertension
Provide signed informed consent

Exclusion Criteria:

Mechanically or chemically-induced ALI/ARDS (including burns, trauma, and near drowning)
End-stage lung disease
Decompensated congestive heart failure
Authorization to withdraw life support
Hemoglobin persistently <8.0 g/dL

Subjects who have any one of the following:

platelet count <50,000/mm^3
prolonged prothrombin time (PT)
prolonged activated partial thromboplastin time (aPTT)
having significant potential for disseminated intravascular coagulation (DIC)

Subjects who have two or more of the following:

prolonged aPTT
fibrinogen level below the lower limit of normal
presence of petechiae, ecchymoses, or other evidence of coagulopathy

Subjects who have a history of one or more of the following:

hematuria (microscopic or gross)
urinary tract neoplasia
nephrolithiasis
glomerulonephritis
active urinary tract infection (UTI)
Bleeding disorders within the past 6 weeks or vasculitis with diffused alveolar hemorrhage
Diagnosis of bleeding peptic ulcer disease within the previous 2 months
Congenital bleeding diatheses such as hemophilia

Treatment with anti-platelet, anti-coagulant agents, or non-steroidal anti-inflammatory drugs (NSAIDs)within 72 hours following infusion of study drug

Therapeutic heparin:

Unfractionated heparin within eight hours prior to study drug infusion
Low molecular weight heparins within the 12 hours prior to study drug infusion

Prophylactic heparin:

Unfractionated heparin >15,000 units/day
Low molecular weight heparins
Warfarin if used within 7 days prior to study drug infusion
Thrombolytic treatment within 3 days prior to study drug infusion
8Glycoprotein IIb/IIIa antagonists within 7 days prior to study drug infusion
Aspirin or any aspirin containing compound within 3 days prior to study drug infusion
APC infusion within 72 hours prior to study drug infusion
Major trauma or trauma subjects at an increased risk of bleeding
History of severe head trauma that required hospitalization, intracranial surgery, or stroke or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion with an epidural catheter or who anticipate receiving an epidural catheter during study drug infusion
Major surgery within the previous 3 days, any postoperative subject with evidence of active bleeding, or any subject with planned or anticipated surgery within 72 hours after study drug infusion. History of abnormal bleeding during surgical procedures
Chronic renal failure, defined as a calculated glomerular filtration rate (GFR) ≤20 mL/min
Subjects with baseline aspartate transaminase (AST) or alanine transaminase (ALT) level >5 times the upper limit of normal. Subjects with known esophageal varices, chronic jaundice, biopsy proven cirrhosis, or chronic ascites
History of organ transplant (including bone marrow)
Subjects with malignancy having a life expectancy <6 months
Known human immunodeficiency virus (HIV) positive with CD4+ T Cell count <200/uL
Women who are pregnant or nursing
Participation in another clinical research study within 30 days before administration of study drug, with the exception of participation in studies involving noninvasive monitoring medical devices
Any prior treatment with a murine or chimeric antibody
Subjects who are moribund and where death is perceived to be imminent (within 72 hours after screening)
Subjects who have persistent hypotension not responding to fluid or vasopressor administration; subjects who require more than two vasopressors 26. Any medical condition which in the opinion of the investigator would interfere with optimal participation in the study or that would produce a significant risk to a subject