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
CorMedix
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
- Age range
- Up to 17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * All participants must be \< 18 years of age and must meet the following inclusion criteria: * The investigator, or a person designated by the investigator, will obtain written informed consent from each study participant's legal guardian and the participant's assent, when applicable, before any study-specific activity is performed. All legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. * A legal guardian or primary caregiver must be available to h…
Interventions
- Drug(taurolidine and heparin) catheter lock solution
for central venous catheter instillation use
- DrugStandard of Care
Site specific standard of care
Locations (4)
- Children's of Alabama/University of AlabamaBirmingham, Alabama
- StanfordPalo Alto, California
- Nemours Children's Hospital - DEWilmington, Delaware
- Cook Children's Health Care SystemFort Worth, Texas