Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream Infections
TaurolockTMHep100 Versus Saline 0.9% As Secondary Prevention of Catheter-related Bloodstream Infections (CRBSI); a Single Center, Double Blinded, Randomized, Controlled Study in Patients with Chronic Intestinal Failure Dependent on Home Parenteral Support (HPS)
1 other identifier
interventional
61
1 country
1
Brief Summary
The purpose of the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedFirst Submitted
Initial submission to the registry
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedOctober 28, 2024
April 1, 2019
2.7 years
October 25, 2024
October 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of recurrent catheter-related bloodstream infections
Treatment time 2 years
Study Arms (2)
TaurolockTMHep100
ACTIVE COMPARATOR0.9% saline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients receiving HPS at the department of Medical gastroenterology, Rigshospitalet, who have at least one prior CRBSI and thereby demonstrated susceptibility towards developing CRBSI while on HPS and the following:
- Signed informed consent form
- Has a single-lumen subcutaneously tunneled CVC
- Has been at least 3 weeks since termination of the antibiotic treatment for their last CRBSI
You may not qualify if:
- Patients who:
- have a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients
- are pregnant, lactating or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- TauroPharmcollaborator
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Related Publications (1)
Nerstrom CT, Scheike T, Moser CE, Tribler S, Jeppesen PB. Taurolidine lock reduces recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: A randomized, placebo-controlled trial in a real-world clinical setting. Clin Nutr. 2025 Aug;51:90-100. doi: 10.1016/j.clnu.2025.05.020. Epub 2025 Jun 3.
PMID: 40554263DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, DMSc, Professor
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 28, 2024
Study Start
June 3, 2019
Primary Completion
February 28, 2022
Study Completion
February 28, 2022
Last Updated
October 28, 2024
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share