A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Three-Arm Study to Evaluate the Safety and Efficacy of Tifacogin (Recombinant Tissue Factor Pathway Inhibitor) Administration in Subjects with Severe Community-Acquired Pneumonia

This study is testing a medicine called tifacogin for adults who are very seriously ill in the ICU with a type of severe pneumonia called community-acquired pneumonia (CAP). This type of pneumonia was caught outside of the hospital and became bad enough to require ICU care. Tifacogin works by blocking a protein involved in inflammation and blood clotting that can be harmful in serious infections. The study compares two different doses of tifacogin to a placebo (inactive treatment) to see which is safest and most effective. You may be eligible if: - You are 18 years of age or older - You have a diagnosis of community-acquired pneumonia with typical signs such as fever, rapid breathing, and changes on chest X-ray - Your pneumonia is severe enough to require ICU admission and either a breathing machine or blood pressure support medicines - Treatment can begin within 36 hours of ICU admission and within 72 hours of hospitalisation You may NOT be eligible if: - You are pregnant - You weigh more than 150 kg - You were hospitalised in the 14 days before this admission - You are a non-mobile resident of a long-term care facility - You require long-term mechanical ventilation - You have known or suspected aspiration pneumonia - You have a bone marrow or organ transplant requiring immunosuppression - You have acute leukemia, multiple myeloma, or lymphoma - You have severe liver disease, very low platelet counts, or high bleeding risk - You have had a cardio-pulmonary arrest in the last 72 hours Talk to your doctor about whether this trial might be right for you.