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

Catheter Related Blood Stream Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826526
• Other study ID #: TCL-0112
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: December 3, 2016
• Start date: June 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Catheter Related Blood Stream Infections
• Infection

Intervention

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.

Locations

Country	Name	City	State
Denmark	University Hospital Copenhagen Rigshospitalet	København
Germany	University Clinic Münster	Münster
Israel	Rabin Medical Center	Petah Tikva
Italy	University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine	Bologna
Netherlands	Department of Gastroenterology and Hepatology clinical ward	Nijmegen
United Kingdom	St Mark's Hospital	Harrow	Middlesex
United Kingdom	University College Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Geert Wanten	Geistlich Pharma AG

Countries where clinical trial is conducted

Denmark,  Germany,  Israel,  Italy,  Netherlands,  United Kingdom, 

References & Publications (1)

Bisseling TM, Willems MC, Versleijen MW, Hendriks JC, Vissers RK, Wanten GJ. Taurolidine lock is highly effective in preventing catheter-related bloodstream infections in patients on home parenteral nutrition: a heparin-controlled prospective trial. Clin — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group		12 months	No
Secondary	Median time to a catheter related blood stream infection CRBSI per patient per group		12 months	No