Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06714864
PHASE4

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

Sponsor: CorMedix

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 17 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-07-08

Completion Date

2026-03

Last Updated

2025-11-04

Healthy Volunteers

No

Interventions

DRUG

(taurolidine and heparin) catheter lock solution

for central venous catheter instillation use

DRUG

Standard of Care

Site specific standard of care

Locations (4)

Children's of Alabama/University of Alabama

Birmingham, Alabama, United States

Stanford

Palo Alto, California, United States

Nemours Children's Hospital - DE

Wilmington, Delaware, United States

Cook Children's Health Care System

Fort Worth, Texas, United States