Catheter Related Infections / (taurolidine and heparin) catheter lock solution · Phase 4 Trial

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

ClinicalTrials.gov · August 5, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 4 post-marketing safety and efficacy registry study of taurolidine-heparin catheter lock solution versus standard care in children aged 0–17 years on chronic hemodialysis. The trial is actively recruiting and has not yet reported results; it is designed to assess time to CRBSI and safety endpoints over up to 13 months.

What was studied

Phase 4, Interventional, Randomized, Parallel, Open label, Prevention purpose. Catheter-Related Infections; to 17 Years. Intervention: DefenCath®. Compared with: Control — Active Comparator. n = 36. 6 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Results from this post-marketing study will establish safety and CRBSI prevention profile of DefenCath in children. Clinicians should await published results before interpreting efficacy or safety claims in this age group.

Plain-language summary

This is an active clinical trial registry record with no reported results; outcomes are planned but not yet posted.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI) (assessed at Patient has been randomized and has received at least 1 instillation of the ass…); Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs (assessed at Patient has been randomized and has received at least 1 instillation of the ass…)

DesignPhase 4, Interventional, Randomized, Parallel, Open label, Prevention purpose

PopulationCatheter-Related Infections; to 17 Years

Sample size36

InterventionDefenCath®

ComparatorControl — Active Comparator

Setting6 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment36

PhasePhase 4

Primary outcome measure 1Time to first clinical diagnosis of CRBSI (up to 13 months)

Primary outcome measure 2Descriptive analysis of relative rates of deaths, AEs, and SAEs (up to 13 months)

Clinical bottom line

Caveats

No results are reported in this registry record; study is currently recruiting.
Open-label design without blinding may introduce bias in clinical diagnosis ascertainment.
Planned enrollment (n=36) is modest and may limit generalizability across pediatric subgroups.
Comparator (Standard of Care) is not explicitly defined in the registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Open-label Phase 4 design; no blinding stated; interventional with active comparator.

Directness

strong

Direct assessment of CRBSI incidence in target pediatric population on chronic HD.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

limited

Open-label design introduces performance and detection bias; no masking reported.

Sample adequacy

limited

Estimated enrollment 36 participants; modest sample for pediatric safety assessment.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06714864). This is a study registration, not published results. Lead sponsor: CorMedix Therapeutics. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Catheter-Related Infections. Interventions: DRUG: (taurolidine and heparin) catheter lock solution; DRUG: Standard of Care. Primary outcome measures: Time to first clinical diagnosis of Catheter-related Bloodstream Infections (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); Descriptive analysis characterizing the relative rates of deaths, AEs, and SAEs , 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). 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CorMedix TherapeuticsNCT06714864Catheter Related Infections(taurolidine and heparin) catheter lock solution