Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%

December 3, 2016 updated by: Geert Wanten

Taurolidine 2% Catheter Locking to Prevent Catheter-related Bloodstream Infections in Patients on Home Parenteral Nutrition With a High Infection Risk and Those With a New Central Venous Access Device

The purpose of this study is to determine if TauroSept® taurolidine 2% is more efficient than saline solution 0.9% as a catheter lock solution in preventing catheter related blood stream infections in patients with home parenteral nutrition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Home Parenteral Nutrition has become a mainstay in the support of patients with chronic intestinal failure. It requires the presence of a central venous catheter to assure adequate venous access. Catheter Related BloodStream Infections (CRBSIs) are frequent. Most CRBSIs originate from contamination of the catheter hub and subsequent growth of microorganisms embedded within the biofilm that rapidly develops on the inner catheter surface. The best preventive measure against the development of CRBSIs is observation of strict hygiene guidelines when inserting and manipulating a central venous catheter and in addition to this the instillation of antimicrobial solutions like TauroSept® or saline solution 0.9% into the catheter lumen (antimicrobial lock). This measure is currently widely used in clinical practice.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København, Denmark, 2100
        • University Hospital Copenhagen Rigshospitalet
  • Germany
      • Münster, Germany, 48149
        • University Clinic Münster
  • Israel
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
  • Italy
      • Bologna, Italy, 40138
        • University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine
  • Netherlands
      • Nijmegen, Netherlands, 6500 HB
        • Department of Gastroenterology and Hepatology clinical ward
  • United Kingdom
      • London, United Kingdom, NW1 2PG
        • University College Hospital
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • St Mark's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Benign underlying disease leading to long-term intestinal failure who will receive HPN and/or fluids (saline and/or glucose) at least 2 times /week over a subcutaneously tunnelled single-lumen Central Venous Catheter (CVC) (Hickman/Broviac or subcutaneous port) for at least one year

    1. Patient receives a new single lumen central vascular access device for HPN (new patient starting HPN or patient already on HPN) allocation to Group I = new catheter group] or
    2. Patient is already on HPN for ≥1 year prior to trial inclusion and has a CRBSI rate (bacterial and/or yeast infections) of >0.3/year and a catheter that has been in place for ≥6 months (allocation to Group II = high risk group). (Previous salvage of this catheter by line-lock antibiotics or other therapeutic interventions is not an exclusion criterion as long as this has been performed at least two months before enrolment in the trial)
  • Estimated life expectancy ≥1 year
  • Male or female patient aged 18 - 80 years
  • Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.

Exclusion Criteria:

  • cannot be expected to comply with the trial plan (substance abuse, mental condition)
  • has significant cardiovascular disease such as unstable angina, acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significant hemodynamic effects
  • has a known hypersensitivity/allergy to taurolidine 2% or saline solution 0.9% and/or their excipients.
  • is pregnant, lactating, or nursing.
  • has a current bloodstream infection
  • has any clinically significant abnormalities in blood coagulation requiring intervention
  • has received thrombolytic therapy in the 6 weeks prior to insertion (aspirin 80-325 mg daily is acceptable).
  • has received an investigational drug within 30 days of trial entry
  • has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
  • has received a Taurolidine lock previously
  • has compromised skin integrity, including any infection at the insertion site
  • has received parenteral or oral antibiotic therapy <2months prior trial inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TauroSept®

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily.

The duration of TauroSept® administration in this trial will be 12 months.
Device: TauroSept®

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily.

The duration of TauroSept® administration in this trial will be 12 months.

Other Names:
  • Taurolidine 2%
Placebo Comparator: Saline solution 0.9%

5 ml of saline will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily.

The duration of saline administration in this trial will be 12 months.
Device: TauroSept®

5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily.

The duration of TauroSept® administration in this trial will be 12 months.

Other Names:
  • Taurolidine 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Median time to a catheter related blood stream infection CRBSI per patient per group
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geert Wanten

Collaborators

Geistlich Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 3, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCL-0112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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