Actively Recruiting
Open-Label Study Comparing DefenCath® Versus Standard Care to Assess Safety and Catheter-Related Bloodstream Infections in Children Under 18 with Kidney Failure on Hemodialysis
Led by CorMedix · Updated on 2026-05-19
36
Participants Needed
6
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and timing of catheter-related bloodstream infections (CRBSI) in children from birth up to 18 years old who have kidney failure and are receiving chronic hemodialysis through a central venous catheter. This is a Phase 4 post-marketing study designed to meet regulatory requirements for the product DefenCath in this pediatric population. Participants will be randomly assigned to receive either DefenCath, a catheter lock solution containing taurolidine and heparin, or the institutional standard of care catheter lock solution. Treatment involves instillation of the assigned lock solution into the central venous catheter used for hemodialysis. The study compares these two approaches to monitor safety and the time until the first clinical diagnosis of CRBSI. During the study, participants will be monitored for up to 13 months for the occurrence of CRBSI, catheter removal due to infection, adverse events, and serious adverse events. Caregivers will assist with follow-up visits, treatments, and assessments according to a schedule set by the study. Researchers will collect data on infection timing and safety outcomes to better understand how these treatments impact children undergoing chronic hemodialysis.
CONDITIONS
Brief Title
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be under 18 years of age
- Legal guardian must provide written informed consent; assent from the participant when applicable
- A legal guardian or primary caregiver must be available to assist with follow-up and study procedures
- Participant has kidney failure and receives chronic hemodialysis at least twice per week
- Participant uses a central venous catheter placed in the jugular or subclavian vein
- Participant has adequate blood flow for dialysis for at least two consecutive sessions
- Participant is expected to require catheter use for at least 60 days
- Participant agrees to comply with follow-up evaluations and dialysis therapy
- Participant is receiving adequate hemodialysis as measured by Kt/V > 1.2 within the last 40 days
- Participant is not expected to expire within 180 days based on clinical assessment
- Female participants of childbearing potential must follow contraception requirements and avoid pregnancy during the study
- Male participants sexually active with females of childbearing potential must use condoms and spermicide during the study
You will not qualify if you...
- Use of systemic antibiotics within the last 14 days (topical antibiotics allowed)
- Visible signs of skin breakdown or infection at catheter exit site
- Use of thrombolytic treatment in current catheter within 30 days, except standard care for patency
- Unknown or undeterminable catheter lumen fill volume
- Use of antimicrobial-coated or heparin-coated catheters
- History of chronic bleeding disorders or recent active bleeding
- History of atrial thrombus or hypercoagulable state
- Presence of open, non-healing skin ulcers
- Current systemic immunosuppression that increases infection risk, including high-dose steroids or certain immunosuppressive drugs
- Active malignancy causing immunosuppression or unstable cancer
- Allergy or contraindication to taurolidine, citrate, or heparin, or history of heparin-induced thrombocytopenia
- Cirrhosis with encephalopathy
- Use of medications known to interact with taurolidine, citrate, or heparin
- Anticipated kidney transplant within 90 days
- Clinically significant cardiac rhythm or functional disorders
- Severe respiratory or circulatory instability prior to randomization
- Other medical conditions preventing study completion or increasing participant risk
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 13 months
Participants receive either the DefenCath® catheter lock solution or standard care as part of their chronic hemodialysis treatment to prevent catheter-related bloodstream infections.
At least 1 instillation of the assigned lock solution, with ongoing dialysis sessions at least twice per week
Trial Site Locations
Total: 6 locations
1
Children's of Alabama/University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
4
Nemours Children's Hospital - DE
Wilmington, Delaware, United States, 19803
Actively Recruiting
5
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
L
Liz Hurlburt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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