Actively Recruiting
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Led by CorMedix · Updated on 2025-11-04
36
Participants Needed
4
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a post-marketing approval requirement to assess the safety and time to Catheter-related Bloodstream Infections (CRBSI) of DefenCath in pediatric population (birth to less than 18 years of age) who are on chronic HD for kidney failure.
CONDITIONS
Official 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 younger than 18 years of age
- Written informed consent from legal guardian and assent from participant when applicable
- A legal guardian or primary caregiver must be available to support follow-up and study visits
- Participant has kidney failure and receives chronic hemodialysis at least twice per week
- Participant uses a central venous catheter placed in jugular or subclavian vein
- Participant has achieved appropriate minimum blood flow for hemodialysis in at least 2 consecutive sessions
- Participant is expected to need central venous catheter use for at least 60 days
- Participant agrees to comply with follow-up evaluations and prescribed dialysis therapy
- Participant is receiving adequate hemodialysis with Kt/V measurement greater than 1.2 within last 40 days
- Participant is not expected to die within 180 days
- Female participants of childbearing potential must agree to contraception requirements and avoid pregnancy during study
- Male participants sexually active with females of childbearing potential must use condoms and spermicide during study
You will not qualify if you...
- Participant has received systemic antibiotics within the last 14 days (topical antibiotics allowed)
- Visible skin damage or infection at catheter exit site
- Received thrombolytic treatment not part of standard care in current catheter within 30 days
- Unknown or undeterminable catheter lumen fill volume
- Use of antimicrobial-coated or heparin-coated catheter
- Chronic bleeding disorder or recent active bleeding within 30 days
- History of atrial thrombus or known hypercoagulable condition
- Open, non-healing skin ulcers
- Current systemic immunosuppression increasing infection risk such as high-dose steroids, biologic immunomodulators, or certain immunosuppressant drugs
- Active malignancy causing immunosuppression or unstable malignancy
- Allergy or contraindication to taurolidine, citrate, or heparin, or history of heparin-induced thrombocytopenia
- Cirrhosis with encephalopathy
- Use of medications with known interactions with study drugs
- Anticipated renal transplant within 90 days
- Significant cardiac rhythm or functional disorders
- Severe respiratory or circulatory instability prior to study
- Any other medical condition preventing study completion or posing significant risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Children's of Alabama/University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Stanford
Palo Alto, California, United States, 94304
Actively Recruiting
3
Nemours Children's Hospital - DE
Wilmington, Delaware, United States, 19803
Actively Recruiting
4
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Actively Recruiting
Research Team
L
Liz Hurlburt
CONTACT
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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