Purpose of this Study
We are doing this study to find out if an experimental drug called DefenCath® (the study drug) is a safe and effective means to lower the risk of central line infections for people who need total parenteral nutrition (TPN). TPN is when people get their necessary nutrients through a catheter in a vein because they are unable to properly digest food for nutrition. We want to know how well the study drug works compared to heparin catheter lock solution, which is the current option to help prevent infections.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Have a permanent central catheter
- Have had a central line infection in past 12 months
- Will require long-term TPN
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will:
- Get a random assignment (like a coin flip) to either get the study drug or get heparin as a 12-month regimen to prevent infections
- Have phone calls every other week with the study team to see how you are doing
- Keep an electronic diary about how you are feeling and any infection symptoms that you may or may not be having
- Visit our clinic about 5 times while you are enrolled in the study to have physical exams and blood draws
Locations
Duke University Hospital
Pickett Road Research
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
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)
Principal Investigator
Paul
Wischmeyer
Protocol Number
PRO00117427
Phase
III
Enrollment Status
Pending Open to Enrollment