NUTRI-GUARD (Infection Prevention for People Using a Catheter for Nutrition)

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
For more information, contact the study team at mary.motta@duke.edu.

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