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NCT06714864 · ClinicalTrials.gov registry record · Phase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
A Phase 4 study of Catheter-Related Infections, sponsored by CorMedix.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 4
- Study locations
NCT06714864: Recruiting Phase 4 study of Catheter-Related Infections, sponsored by CorMedix.
NCT06714864 is a Phase 4 study of Catheter-Related Infections that is actively recruiting participants, run by CorMedix. The registered enrollment target is 36 participants, below the 2,090-participant average among 5 other Catheter-Related Infections trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06714864, a Phase 4 study of Catheter-Related Infections, is actively recruiting participants, sponsored by CorMedix.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
To demonstrate the effectiveness of DefenCath as a catheter lock solution (CLS) for prevention of CRBSI in pediatric participants receiving chronic hemodialysis (HD) through a central venous catheter (CVC) for the treatment of kidney failure.
Conditions Studied
Interventions
- DRUG Standard of Care
- DRUG (taurolidine and heparin) catheter lock solution
Study Locations (4)
Alabama
- Children's of Alabama/University of Alabama - Birmingham
California
- Stanford - Palo Alto
Delaware
- Nemours Children's Hospital - DE - Wilmington
Texas
- Cook Children's Health Care System - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-07-08 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
What NCT06714864 shows while recruiting
NCT06714864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 2,090-participant average among 5 other Catheter-Related Infections trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Catheter-Related Infections appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT06714864 reports a single indexed study location in Alabama, California, Delaware.
Frequently Asked Questions
What is clinical trial NCT06714864 about?
NCT06714864 is a clinical study titled "Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age". 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.
What is the current status of trial NCT06714864?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2025-07-08. Estimated completion is 2026-03.
What conditions does trial NCT06714864 study?
This clinical trial studies the following conditions: Catheter-Related Infections.
What interventions are being tested in trial NCT06714864?
The interventions under investigation include: Standard of Care (DRUG), (taurolidine and heparin) catheter lock solution (DRUG).
Who is sponsoring clinical trial NCT06714864?
This trial is sponsored by CorMedix, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06714864 being conducted?
This trial has 4 study locations across Alabama, California, Delaware, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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