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

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ClinicalTrials.gov Identifier: NCT01826526
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : December 6, 2016
Sponsor:
Collaborator:
Geistlich Pharma AG
Information provided by (Responsible Party):
Geert Wanten, Radboud University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Catheter Related Blood Stream Infections Device: TauroSept® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

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 Name: 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 Name: Taurolidine 2%




Primary Outcome Measures :
  1. Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Median time to a catheter related blood stream infection CRBSI per patient per group [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826526


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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geert Wanten, MD, PhD, MSc, Radboud University
ClinicalTrials.gov Identifier: NCT01826526     History of Changes
Other Study ID Numbers: TCL-0112
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Infection
Taurolidine
Anti-Infective Agents
Anti-Infective Agents, Local
Antineoplastic Agents