Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1... | NCT06660641

Official Title

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)

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2019Actual

Primary Completion Date

Feb 28, 2022Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

Oct 25, 2024

First Submission Date that Met QC Criteria

Oct 25, 2024

First Posted Date

Oct 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2024

Last Update Posted Date

Oct 28, 2024Actual

Name	Class
TauroPharm	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients with long-term intestinal failure rely on Home Parenteral support (HPS) delivered through a central venous catheter(CVC). Catheter Related Blood Stream Infections(CRBSI) are a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of the CVC. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.

The primary objective is to compare two catheter lock solutions, 1,35% taurolidine and 0.9% saline, on the occurence of recurrent CRBSIs. The secondary objectives are to compare the two devices according to other catheter-related complications, adverse events and costs.

Patients with at least one prior CRBSI is included. Patients instill the solution in their CVC after each infusion of HPS, with a minimum of three times per week, depending on their individual HPS programme.

Before the blinded randomization the patients will be paired according to age and stratified according to prior CRBSI incidence.

Duration of the instillation will be 24 months.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TaurolockTMHep100	Active Comparator		Device: TaurolockTMHep100
0.9% saline	Placebo Comparator		Device: 0.9 % saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TaurolockTMHep100	Device	1.35% taurolidine containing catheter losk solution	TaurolockTMHep100

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of recurrent catheter-related bloodstream infections		Treatment time 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who:

have a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients
are pregnant, lactating or nursing

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen		2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42235100	Derived	Nerstrom CT, Scheike T, Moser CE, Tribler S, Jeppesen PB. Cost-effectiveness of Taurolidine as secondary prevention of recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: Findings from a randomized controlled trial. Clin Nutr. 2026 Jul;62:106694. doi: 10.1016/j.clnu.2026.106694. Epub 2026 May 22.
40554263

ID	Term
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases