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

Conditions

• Catheter-Related Infections

Eligibility Criteria

Sex

ALL

Age

N/A - 17 Years

Healthy Volunteers

Not accepted

Interventions

• (taurolidine and heparin) catheter lock solution — DRUG
  for central venous catheter instillation use
• Standard of Care — DRUG
  Site specific standard of care

Study Details

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.

Key Dates

Start date

Jul 8, 2025

Status verified

May 2026

Primary completion

Jul 31, 2028

Completion

Apr 30, 2029

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: DefenCath®
• Active Comparator: Control

Primary Outcome Measure

Time to first clinical diagnosis of Catheter-related Bloodstream Infections (CRBSI) [ Time Frame: 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) ]

Central Contacts

• Liz Hurlburt
  9085179500
  [email protected]

Locations (6)

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