Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome

Inclusion Criteria

• •1. Suspected or proven infection
• •2. Hypoxemia: PaO2/FiO2is ≤300 mm Hg
• •3. Bilateral infiltrates consistent with pulmonary edema
• •4. Positive-pressure mechanical ventilation through an endotracheal tube
• •5. No clinical evidence of left atrial hypertension to explain bilateral infiltrates
• •6. Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC
• •Criteria 2 and 3 must occur within a 24-hour interval. The 48-hour enrollment time window begins when criteria 2, 3, and 4 are met.
• •12. Neuromuscular disease that impairs ability to ventilate without assistance
• •13. Severe chronic respiratory disease, severe pulmonary hypertension, or ventilator dependency
• •14. Chest wall deformity resulting in severe exercise restriction, secondary polycythemia, or respirator dependent
• •15. History of organ transplant (including bone marrow)
• •16. Severe chronic liver disease, as determined by a Child-Pugh Score \>10
• •17. Hemoglobin persistently \< 7.0 g/dL
• •18. Platelet count \<50,000/mm3
• •19. Prolonged INR \>3
• •20. Bleeding disorders unless corrective surgery has been performed
• •21. Active internal bleeding
• •22. Major surgery within 24 hours before study drug infusion, or evidence of active bleeding postoperatively, or plan for any major surgery within 3 days after study drug infusion.
• •23. Diffuse alveolar hemorrhage from vasculitis
• •24. Known bleeding diathesis
• •25. Presence of an epidural catheter or lumbar puncture within 48 hours before study drug infusion or anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after study drug infusion
• •26. Stroke within 3 months of study entry
• •27. Trauma with an increased risk of life-threatening bleeding
• •28. A history of severe head trauma that required hospitalization, or intracranial surgery within two months of study entry
• •29. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion
• •30. Uses of certain medications or treatment regimens such as chemotherapy, unfractionated heparin, low-molecular-weight heparin, Warfarin, antithrombin III, acetylsalicylic acid, glycoprotein IIb/IIIa antagonists, thrombolytic therapy, and activated Protein C are restricted.
• •31. Participation in another experimental medication study within 30 days of study entry.