RecruitingPhase 4NCT06714864

Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age

An Open-Label, Two-Arm (DefenCath® vs. Institutional Standard of Care) Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to Less Than 18 Years of Age With Kidney Failure Receiving Hemodialysis Via a Central Venous Catheter

Sponsor

CorMedix

Enrollment

36 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

Catheter-Related Infections

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.

Eligibility

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called (taurolidine and heparin) catheter lock solution and a drug called Standard of Care for people with catheter-related infections. The study is currently recruiting participants at 6 locations. People eligible for this study include up to age 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG(taurolidine and heparin) catheter lock solution

for central venous catheter instillation use

DRUGStandard of Care

Site specific standard of care

Locations(6)

Children's of Alabama/University of Alabama

Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Stanford

Palo Alto, California, United States

Nemours Children's Hospital - DE

Wilmington, Delaware, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Cook Children's Health Care System

Fort Worth, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06714864

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