Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC)

Conditions

• Central Line Associated Blood Stream Infections (CLABSI)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• (taurolidine and heparin) catheter lock solution — DRUG
  for central venous catheter installation use
• Heparin — DRUG
  Heparin

Study Details

This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.

Key Dates

Start date

May 14, 2025

Status verified

May 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: DefenCath®
• Active Comparator: Control

Primary Outcome Measure

Comparison between treatment groups of proportion of participants who experience a Central Line-Associated Bloodstream Infections (CLABSI) within 12 months of the start of the study [ Time Frame: Self-administered by participants (or a designated caregiver) per the participants regular TPN/ line access schedule, through study completion (up to 12 months) ]

Central Contacts

• Liz Hurlburt, Chief Clinical Strategy & Operations Officer
  908-517-9500
  [email protected]

Locations (17)

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