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

NCT06714864 | Recruiting Phase 4 FDA Drug

• 1 other identifier: PEDI-LOCK
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Catheter-Related Infections

Outcome Measures

Primary Outcomes (2)

• Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI)

  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.

  Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

• Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs

  To demonstrate safety of DefenCath as a CLS in pediatric participants receiving chronic HD through a CVC for the treatment of kidney failure

  Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Secondary Outcomes (1)

• Time to catheter removal due to CRBSI

  Patient has been randomized and has received at least 1 instillation of the assigned lock solution, and has received confirmed diagnosis of CRBSI (up to 13 months)

Study Arms (2)

DefenCath®

EXPERIMENTAL

Drug: (taurolidine and heparin) catheter lock solution

Control

ACTIVE COMPARATOR

Drug: Standard of Care

Interventions

(taurolidine and heparin) catheter lock solution DRUG

for central venous catheter instillation use

Also known as: DefenCath®

DefenCath®

Standard of Care DRUG

Site specific standard of care

Control

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 help the study-site personnel ensure follow up; accompany the participant to the study site on each assessment day according to the schedule of activities (SoA) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); consistently and consecutively be available to provide information on the participant during the scheduled study visits; accurately and reliably dispense study intervention as directed.
• The participant has kidney failure and undergoes chronic hemodialysis (HD) at least 2 times per week.
• The participant has an HD central venous catheter (CVC) and is placed in a jugular or subclavian vein.
• The participant has demonstrated the ability to achieve an appropriate minimum blood flow (Qb) for the participant's relative age and weight for at least 2 consecutive dialysis sessions to enable successful HD.
• The participant is likely to require the use of a CVC for at least 60 days, based on clinical assessment.
• The participant is willing to comply with specified follow-up evaluations and prescribed dialysis therapy.
• The participant is receiving adequate HD as assessed by the investigators and based on a single pool Kt/V measurement \> 1.2 (within the last 40 days).
• The participant is not expected to expire within 180 days, based on clinical assessment.
• Female participants of childbearing potential:
• Must agree to abide by contraception requirements, must not be lactating, and avoid pregnancy during study participation from the first Screening visit until 30 days after the last administration of study treatment.
• Must commit to an additional method of birth control in addition to male partners agreeing to use condoms with spermicide, throughout the study including for at least 30 days after the last administration of study treatment:
• True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post ovulation methods\] and withdrawal are not acceptable).
• Combined (containing estrogen and progestogen) hormonal birth control (oral, intravaginal, injectable, or transdermal) associated with inhibition of ovulation initiated at least 30 days before dose administration.
• Progestogen only hormonal birth control (oral, injectable, or implantable) associated with inhibition of ovulation initiated at least 30 days before study dose administration.

You may not qualify if:

• The participant has received systemic antibiotics within the last 14 days. Topical antibiotic use is permitted.
• Visible evidence of compromised skin integrity is present at the catheter exit site or evidence of a catheter exit site infection.
• The participant has received any thrombolytic treatment (i.e., tissue plasminogen activator \[tPA\] - Cathflo®), not as part of the institution's standard of care for patency management, in their current catheter within 30 days of randomization.
• The fill volume of catheter lumen(s) is unknown or cannot be determined.
• The participant uses any type of antimicrobial-coated or heparin-coated catheter.
• Documented chronic bleeding diathesis, active or recurrent bleeding within 30 days prior to randomization.
• Documented history of an atrial thrombus or known hypercoagulable state.
• The participant has open, non-healing skin ulcers.
• Current requirement for systemic immunosuppression that would increase risk of infection, such as:
• High dose steroid. Low-dose steroids, such as routinely used for maintenance of organ transplants, are acceptable.
• Methotrexate dose sufficiently high to suppress white blood cells (WBC) below 5,000 cells/µL.
• Biologic immunomodulators (anti-tumour necrosis factor, anti-CD4 antibody, etc.) within 30 days.
• Azathioprine.
• Calcineurin inhibitors (dose determined by investigator).
• Sirolimus.

Sponsors & Collaborators

• CorMedix: lead

Study Sites (4)

Children's of Alabama/University of Alabama

Birmingham, Alabama, 35233, United States

RECRUITING

Stanford

Palo Alto, California, 94304, United States

RECRUITING

Nemours Children's Hospital - DE

Wilmington, Delaware, 19803, United States

RECRUITING

Cook Children's Health Care System

Fort Worth, Texas, 76104, United States

RECRUITING

MeSH Terms

Conditions

Catheter-Related Infections

Interventions

taurolidine; Heparin; Standard of Care

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Liz Hurlburt

CONTACT

9085179500; lhurlburt@cormedix.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 4, 2024
• Study Start: July 8, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (4)