Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Catheter Related Blood Stream Infections Intestinal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TaurolockTMHep100

Group Type ACTIVE_COMPARATOR

TaurolockTMHep100

Intervention Type DEVICE

1.35% taurolidine containing catheter losk solution

0.9% saline

Group Type PLACEBO_COMPARATOR

0.9 % saline

Intervention Type DEVICE

placebo

Interventions

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TaurolockTMHep100

1.35% taurolidine containing catheter losk solution

Intervention Type DEVICE

0.9 % saline

placebo

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No