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

Primary Purpose

Catheter Related Blood Stream Infections

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

TauroSept®

About this trial

This is an interventional prevention trial for Catheter Related Blood Stream Infections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Copenhagen Rigshospitalet
University Clinic Münster
Rabin Medical Center
University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine
Department of Gastroenterology and Hepatology clinical ward
St Mark's Hospital
University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TauroSept®

Saline solution 0.9%

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group

Secondary Outcome Measures

Median time to a catheter related blood stream infection CRBSI per patient per group

Full Information

NCT ID

NCT01826526

First Posted

March 5, 2013

Last Updated

December 3, 2016

Sponsor

Geert Wanten

Collaborators

Geistlich Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT01826526

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Geert Wanten

Collaborators

Geistlich Pharma AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Catheter Related Blood Stream Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TauroSept®

Arm Type

Active Comparator

Arm Description

Arm Title

Saline solution 0.9%

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

TauroSept®

Other Intervention Name(s)

Taurolidine 2%

Intervention Description

Primary Outcome Measure Information:

Title

Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Median time to a catheter related blood stream infection CRBSI per patient per group

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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 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 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

Facility Information:

Facility Name

University Hospital Copenhagen Rigshospitalet

City

København

ZIP/Postal Code

2100

Country

Denmark

Facility Name

University Clinic Münster

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Rabin Medical Center

City

Petah Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Department of Gastroenterology and Hepatology clinical ward

City

Nijmegen

ZIP/Postal Code

6500 HB

Country

Netherlands

Facility Name

St Mark's Hospital

City

Harrow

State/Province

Middlesex

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

University College Hospital

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

20061070

Citation

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 Nutr. 2010 Aug;29(4):464-8. doi: 10.1016/j.clnu.2009.12.005. Epub 2010 Jan 12.

Results Reference

result

PubMed Identifier

29978597

Citation

Wouters Y, Theilla M, Singer P, Tribler S, Jeppesen PB, Pironi L, Vinter-Jensen L, Rasmussen HH, Rahman F, Wanten GJA. Randomised clinical trial: 2% taurolidine versus 0.9% saline locking in patients on home parenteral nutrition. Aliment Pharmacol Ther. 2018 Aug;48(4):410-422. doi: 10.1111/apt.14904. Epub 2018 Jul 5.

Results Reference

derived

PubMed Identifier

29722835

Citation

Tribler S, Brandt CF, Fuglsang KA, Staun M, Broebech P, Moser CE, Scheike T, Jeppesen PB. Catheter-related bloodstream infections in patients with intestinal failure receiving home parenteral support: risks related to a catheter-salvage strategy. Am J Clin Nutr. 2018 May 1;107(5):743-753. doi: 10.1093/ajcn/nqy010.

Results Reference

derived

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

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