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Recombinant tissue factor pathway inhibitor in severe community-acquired pneumonia: a randomized trial.

Authors
Wunderink, RG; Laterre, PF; Francois, B; Perrotin, D; Artigas, A; Vidal, LO; Lobo, SM; Juan, JS; Hwang, SC; Dugernier, T; LaRosa, S; Wittebole, X; Dhainaut, JF; Doig, C; Mendelson, MH; Zwingelstein, C; Su, G; Opal, S; CAPTIVATE Trial Group
Citation
American journal of respiratory and critical care medicine, 183(11):1561-1568, 2011
Journal Title
American journal of respiratory and critical care medicine
ISSN
1073-449X1535-4970
Abstract
RATIONALE: Severe community-acquired pneumonia (sCAP) is a leading cause of death worldwide. Adjunctive therapies for sCAP are needed to further improve outcome. A systemic inhibitor of coagulation, tifacogin (recombinant human tissue factor pathway inhibitor) seemed to provide mortality benefit in the sCAP subgroup of a previous sepsis trial.



OBJECTIVES: Evaluate the impact of adjunctive tifacogin on mortality in patients with sCAP.



METHODS: A multicenter, randomized, placebo-controlled, double-blind, three-arm study was conducted from July 2005 to June 2008 at 188 centers in North and South America, Europe, South Africa, Asia, Australia, and New Zealand. Adults with sCAP were randomized to receive a continuous intravenous infusion of tifacogin 0.025 mg/kg/h, tifacogin 0.075 mg/kg/h, or matching placebo over 96 hours.



MEASUREMENTS AND MAIN RESULTS: Severity-adjusted 28-day all-cause mortality. Of 2,138 randomized patients, 946, 238, and 918 received tifacogin 0.025 mg/kg/h, tifacogin 0.075 mg/kg/h, and placebo, respectively. Tifacogin 0.075 mg/kg/h was discontinued after the first interim analysis according to prespecified futility criterion. The 28-day all-cause mortality rates were similar between the 0.025 mg/kg/h (18%) and placebo groups (17.9%) (P = 0.56). Greater reduction in prothrombin fragment 1+2 and thrombin antithrombin complexes levels relative to baseline throughout the first 96 hours was found with tifacogin 0.025 mg/kg/h than with placebo. The incidence of adverse events and serious adverse events were comparable between the tifacogin 0.025 mg/kg/h and placebo groups.



CONCLUSIONS: Tifacogin showed no mortality benefit in patients with sCAP despite evidence of biologic activity.
MeSH terms
AdultAgedAnti-Bacterial Agents/*therapeutic useCommunity-Acquired InfectionsDouble-Blind MethodFemaleHumansInfusions, IntravenousMaleMiddle AgedPneumonia/*drug therapyProteins/administration & dosage/*therapeutic useSeverity of Illness IndexSurvival AnalysisTreatment Outcome
DOI
10.1164/rccm.201007-1167OC
PMID
21297074
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Medical Science
AJOU Authors
황, 성철
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