Actively Recruiting
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)
Led by CorMedix · Updated on 2025-12-24
200
Participants Needed
15
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who are resident within the US and Türkiye.
- Participants who are male or female, aged 6518 years at the time of consent.
- Participants must sign and provide informed consent.
- Participants who have a permanent tunneled CVC or permanent PICC made of silicone or polyurethane, which has been in place for at least 7 days prior to enrollment.
- Participants who require long-term (>6 months) TPN based on the investigator assessments.
- Participants who require TPN for at least 3 days per week, of which 2 days have to be parenteral nutrition (PN).
- Participants who have a minimum of a 4-hour CLS dwelling time and are willing to lock all lumens at a minimum of every 7 days.
- Participants who are clinically stable, in the opinion of the investigator, for at least 4 weeks prior to enrollment.
- Participants who are able and willing to be trained or have a caregiver who is willing and able to be trained on the instillation, aspiration of DefenCath or heparin, and to maintain a daily diary.
- Female participants of childbearing potential must have a negative pregnancy test at screening, not be lactating, and use acceptable contraception for the duration of the program until at least 30 days after last DefenCath use.
- Male participants sexually active with female partners of childbearing potential must agree to use condoms with spermicide (or condoms alone if vasectomized) during the study and for 30 days after last DefenCath use.
- Participants who comply with all study procedures and follow-up evaluations.
You will not qualify if you...
- Unable or unwilling to sign informed consent.
- Received systemic antibiotic within the last 14 days (topical antibiotics allowed).
- Visible compromised skin integrity or infection at catheter exit site.
- Temporary, non-tunneled CVC or temporary PICC.
- Received thrombolytic treatment in current catheter within 30 days of randomization.
- Unstable arrhythmia with hemodynamic instability within 1 month before baseline.
- Use of antimicrobial-coated or heparin-coated catheters.
- Chronic bleeding disorders or active/recurrent bleeding within 1 month before randomization.
- Congenitally lethal condition or life expectancy under 6 months.
- History of atrial thrombus or known hypercoagulable state.
- Open, non-healing skin ulcer.
- Bone marrow transplant within last year.
- Neutropenia with absolute neutrophil count <1000 cells/bcL.
- Current systemic immunosuppression increasing infection risk (e.g., high-dose steroids, chemotherapy, certain immunosuppressive drugs).
- Allergies or contraindications to citrate, taurolidine, or heparin; history of heparin-induced thrombocytopenia.
- Taking medications with known interactions with citrate, taurolidine, or heparin.
- Anticipating transplant within 90 days.
- Pregnant or lactating.
- Receiving continuous TPN infusion over 24 hours.
- Medical conditions preventing study completion or causing significant risk.
- Participation in another interventional clinical study except non-pharmacological research.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90024
Actively Recruiting
2
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Bioresearch Partner
Doral, Florida, United States, 33122
Actively Recruiting
4
Emory University Hospital - GCRC
Atlanta, Georgia, United States, 30322
Actively Recruiting
5
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Johns Hopkins Clinical Research Unit
Baltimore, Maryland, United States, 21205
Actively Recruiting
7
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3285
Actively Recruiting
9
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
10
Duke University Hospital
Durham, North Carolina, United States, 27710
Active, Not Recruiting
11
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
13
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
14
Vanderbilt Center for Human Nutrition
Nashville, Tennessee, United States, 37212-1150
Actively Recruiting
15
Alchemi - Sugarland
Sugar Land, Texas, United States, 77478
Actively Recruiting
Research Team
L
Liz Hurlburt, Chief Clinical Strategy & Operations Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here