Pronto disponible para inscripción
This study will open for enrollment soon. Please contact the study team for more information and check back frequently.
NUTRI-GUARD (Infection Prevention for People Using a Catheter for Nutrition) - Clinical Trial
What is the 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.
What is the Condition Being Studied?
Prevention of Central Line Infections for Patients Receiving Total Parenteral Nutrition (TPN)
Who Can Participate in the Study?
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.
Grupo etario
Adultos
What is Involved?
Si elige unirse a este estudio, podrá:
- 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
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
Especialista en anestesiología
Protocol Number
IRB:
PRO00117427
Phase
Phase
III
Estado de inscripción
Pronto disponible para inscripción