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)
CorMedix
Summary
This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
1. Participants who are resident within the US and Türkiye. 2. Participants who are male or female, aged ≥18 years at the time of consent. 3. Participants must sign and provide informed consent. 4. Participants who have a permanent tunneled CVC or permanent peripherally inserted central catheter (PICC) made of silicone or polyurethane, which has been in place for at least 7 days prior to enrollment. 5. Participants who require long-term (\>6 months) TPN based on the investigator assessments. 6. Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nut…
Interventions
- Drug(taurolidine and heparin) catheter lock solution
for central venous catheter installation use
- DrugHeparin
Heparin
Locations (15)
- University of California Los AngelesLos Angeles, California
- MedStar Health Research InstituteWashington D.C., District of Columbia
- Bioresearch PartnerDoral, Florida
- Emory University Hospital - GCRCAtlanta, Georgia
- University of Iowa Health CareIowa City, Iowa
- Johns Hopkins Clinical Research UnitBaltimore, Maryland