Actively Recruiting
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)
Led by CorMedix · Updated on 2026-05-20
200
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of DefenCath, a catheter lock solution, compared to heparin in adults receiving long-term home Total Parenteral Nutrition (TPN) through a central venous catheter (CVC). This Phase 3, randomized, double-blind, controlled, adaptive study aims to reduce central line-associated bloodstream infections (CLABSIs) in this population. The study is conducted at multiple centers and sponsored by CorMedix. Participants will be randomly assigned to receive either DefenCath or heparin as a catheter lock solution for their central venous catheter. The study includes two groups: one using DefenCath (taurolidine and heparin) and the other using heparin alone. Treatments will be applied according to the participants' regular TPN and line access schedule, with catheter lumens locked at least every 7 days. The study lasts up to 12 months. During the study, participants or their caregivers will self-administer the catheter lock solution and maintain a daily diary. Researchers will monitor the proportion of participants who develop CLABSIs within 12 months and track adverse events, laboratory tests, vital signs, and physical exams throughout the study. Participants will be followed closely for safety and treatment effects over the entire study period, which may last up to a year.
CONDITIONS
Brief 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 residents within the US and Türkiye
- Male or female participants aged 18 years or older at the time of consent
- Participants who sign and provide informed consent
- Participants with a permanent tunneled CVC or permanent PICC made of silicone or polyurethane, in place for at least 7 days prior to enrollment
- Participants requiring long-term (>6 months) TPN based on investigator assessment
- Participants requiring TPN for at least 3 days per week, with at least 2 days of parenteral nutrition
- Participants with a minimum 4-hour central line system dwelling time, willing to lock all lumens at least every 7 days
- Participants clinically stable for at least 4 weeks prior to enrollment
- Participants able and willing to be trained, or with a caregiver able and willing to be trained, on catheter lock instillation and diary maintenance
- Women of childbearing potential must have a negative pregnancy test, not be lactating, and use acceptable contraception during the study and for 30 days after last DefenCath instillation
- Male participants with female partners of childbearing potential must use condoms with spermicide (or condoms alone if vasectomized) during the study and for 30 days after last DefenCath instillation
- Participants who comply with all study procedures and follow-up evaluations
You will not qualify if you...
- Participants unable or unwilling to sign informed consent
- Participants who received systemic antibiotics within the last 14 days (topical antibiotics and certain treatments for SIBO allowed)
- Participants with compromised skin integrity or infection at catheter exit site
- Participants with temporary, non-tunneled CVC or temporary PICC
- Participants who received thrombolytic treatment in current catheter within 30 days, outside standard care
- Participants with unstable arrhythmia within 1 month prior to baseline
- Participants using antimicrobial-coated or heparin-coated catheters
- Participants with chronic bleeding disorders or active/recurrent bleeding within 1 month prior to randomization
- Participants with lethal conditions or life expectancy less than 6 months
- Participants with history of atrial thrombus or known hypercoagulable state
- Participants with open, non-healing skin ulcers
- Participants who had bone marrow transplant within last year
- Participants with neutropenia (absolute neutrophil count <1000 cells/µL)
- Participants requiring systemic immunosuppression increasing infection risk (including steroids, chemotherapy, methotrexate, azathioprine, calcineurin inhibitors above specified doses)
- Participants allergic or contraindicated to citrate, taurolidine, or heparin or with history of heparin-induced thrombocytopenia
- Participants taking medications interacting with citrate, taurolidine, or heparin
- Participants anticipating transplant within 90 days
- Pregnant or lactating participants
- Participants receiving continuous 24-hour TPN infusion
- Participants with medical conditions interfering with study completion or posing risk
- Participants currently in another interventional clinical study, except non-pharmacological research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either the DEFENCATH® catheter lock solution or heparin catheter lock solution through their central venous catheter as part of their regular total parenteral nutrition (TPN) care.
Visits occur according to participants' regular TPN/line access schedule
Trial Site Locations
Total: 22 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 Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
6
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Actively Recruiting
7
Johns Hopkins Clinical Research Unit
Baltimore, Maryland, United States, 21205
Actively Recruiting
8
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-3285
Actively Recruiting
10
Mount Sinai Medical Center
New York, New York, United States, 10029
Actively Recruiting
11
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Duke University Hospital
Durham, North Carolina, United States, 27710
Withdrawn
13
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
14
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
16
Vanderbilt Center for Human Nutrition
Nashville, Tennessee, United States, 37212-1150
Actively Recruiting
17
Alchemi - Sugarland
Sugar Land, Texas, United States, 77478
Actively Recruiting
18
Hacettepe University Hospitals
Altındağ, Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
19
Ankara University Ibni Sina Research and Application Hospital
Çankaya, Ankara, Turkey (Türkiye), 06230
Not Yet Recruiting
20
Ankara Bilkent City Hospital
Çankaya, Ankara, Turkey (Türkiye), 06800
Not Yet Recruiting
21
Hacettepe University Hospitals
Yenimahalle, Ankara, Turkey (Türkiye), 06560
Not Yet Recruiting
22
Istanbul University Faculty of Medicine, Capa State Hospital
Istanbul, Turkey (Türkiye), 34093
Not Yet Recruiting
Research Team
L
Liz Hurlburt, Chief Clinical Strategy & Operations Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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