Bradley R. Salonen, M.D.

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• A PHASE 3, PROSPECTIVE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CONTROLLED, ADAPTIVE STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF DEFENCATH® IN REDUCING CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTIONS (CLABSIS) IN ADULT PARTICIPANTS RECEIVING TOTAL PARENTERAL NUTRITION (TPN) VIA CENTRAL VENOUS CATHETER (CVC) Rochester, Minn.

  The purpose of this study is evaluate the efficacy of DefenCath in reducing the incidence of CLABSI over 12 months compared with heparin as a catheter lock solution (CLS) in an adult study population receiving TPN via CVC. The adjusted estimates of the proportion of participants who remain infection-free will be derived from the Kaplan-Meier analysis and the primary focus of the analysis.