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)

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Failure; Catheter Related Blood Stream Infections
• Intervention / Treatment: Device: TaurolockTMHep100; Device: 0.9 % saline

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

1. Signed informed consent form
2. Has a single-lumen subcutaneously tunneled CVC
3. Has been at least 3 weeks since termination of the antibiotic treatment for their last CRBSI

Exclusion Criteria:

Patients who:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 0.9% saline	Device: 0.9 % saline; placebo
Active Comparator: TaurolockTMHep100	Device: TaurolockTMHep100; 1.35% taurolidine containing catheter losk solution

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: TauroPharm

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Taurolidine; Catheter-related bloodstream infections; Intestinal failure
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Intestinal Failure; Sepsis; Infections; Communicable Diseases
• Other Study ID Numbers: H-19000051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No