Phase 3 Study to Test Safety and Effectiveness of DefenCath Compared to Heparin in Preventing Bloodstream Infections in Adults Using Central Venous Catheters for Long-Term Total Parenteral Nutrition

What this Trial Is About

Researchers are conducting a Phase 3, randomized, double-blind, controlled study to evaluate the safety and effectiveness of DefenCath compared with heparin in adults who receive home Total Parenteral Nutrition TPN via a Central Venous Catheter CVC. The study aims to reduce central line-associated bloodstream infections CLABSIs in this population by comparing these two catheter lock solutions. Participants will be randomly assigned to receive either DefenCath, a catheter lock solution containing taurolidine and heparin, or heparin alone. The study is adaptive and involves two groups across multiple centers. Treatments are administered through the central venous catheter as part of routine TPN care, with participants or their caregivers managing the instillation and aspiration according to their regular TPN schedule. The study duration extends up to 12 months for each participant. During the study, participants or their caregivers will maintain a daily diary and self-administer assessments related to catheter use and infections. Researchers will monitor the occurrence of bloodstream infections as the main outcome within 12 months. Additional evaluations include tracking adverse events, laboratory results, vital signs, and physical exam findings. The study is designed to ensure participant safety and thorough follow-up throughout the treatment period.

Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)