TREATMENT WITH THE PLATELET-ACTIVATING-FACTOR ANTAGONIST TCV-309 IN PATIENTS WITH SEVERE SYSTEMIC INFLAMMATORY RESPONSE SYNDROME - A PROSPECTIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED PHASE-II TRIAL

In a prospective randomized, double-blind, placebo-controlled clinical study, the safety and efficacy of the platelet-activating factor anta gonist TCV-309 in the treatment of systemic inflammatory response synd rome was studied. In total 29 patients were treated with 1.0 mg/kg TCV -309 twice daily during 7 days or with placebo. Study parameters were as follows: adverse events, 28 and 56 day all cause mortality, multi-o rgan failure scores, and the inflammatory mediators tumor necrosis fac tor, interleukin 6, interleukin 8, and soluble E-selectin. There was n o difference in number and severity of adverse events between TCV-309- and placebo-treated patients. Day 28 and day 56 mortality was similar in both groups (day 56: 7/12 TCV-309 vs. 9/16 placebo, NS). Pulmonary and hematological failure scores improved significantly in TCV-309-tr eated patients (p < .05). There was no difference in inflammatory medi ator levels between TCV-309- and placebo-treated patients. Treatment w ith TCV-309 appears to be safe in patients with systemic inflammatory response syndrome and does improve organ failure significantly.