Catheter Related Blood Stream InfectionsNCT01826526
Clinical Trial With Catheter Locking TauroSept® (Taurolidine 2%) or Saline Solution 0,9%
A study testing TauroSept® in people with Catheter Related Blood Stream Infections, run by Geert Wanten at 7 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Catheter Related Blood Stream Infections
- What is being tested?
- TauroSept®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Jun 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
United Kingdom2 sites
St Mark's Hospital
Harrow, Middlesex, HA1 3UJ
University College Hospital
London, NW1 2PG
Italy1 site
University of Bologna Center for Chronic Intestinal Failure Department of Gastroenterology and Internal Medicine
Bologna, 40138
Netherlands1 site
Department of Gastroenterology and Hepatology clinical ward
Nijmegen, 6500 HB
About this study
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
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.
Read the 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.
- Conditions
- Catheter Related Blood Stream Infections
- Being tested
- TauroSept®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauroSept®Device
Also called Taurolidine 2%
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.
| Study group | Role | What they receive |
|---|---|---|
| TauroSept® | Active comparator | 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. Receives: Device: TauroSept® |
| Saline solution 0.9% | Placebo comparator | 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. Receives: Device: TauroSept® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group
Measured: 12 months
Secondary outcomes (1)
Median time to a catheter related blood stream infection CRBSI per patient per group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheter Related Blood Stream InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geert Wanten
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor-investigator, Geert Wanten, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826526
- Sponsor's protocol ID
- TCL-0112
- Status last verified
- Dec 2016
- First submitted
- 5 Mar 2013
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20061070Wouters 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.
PubMed 29978597Tribler 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.
PubMed 29722835
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01826526
- Acronym / sponsor ID
- TCL-0112
- Conditions
- Catheter Related Blood Stream Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Geert WantenUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- Jun 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TauroSept® | Active comparator | 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. |
| Saline solution 0.9% | Placebo comparator | Device: TauroSept®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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TauroSept®Also: Taurolidine 2%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 | Saline solution 0.9%, TauroSept® |
Primary outcome
Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group
Time frame: 12 months
1 secondary outcome
Median time to a catheter related blood stream infection CRBSI per patient per group
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Results publication: PubMed 20061070Bisseling 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.
- Derived from this study: PubMed 29978597Wouters 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.
- Derived from this study: PubMed 29722835Tribler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TauroSept® in people with Catheter Related Blood Stream Infections, run by Geert Wanten at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Denmark, Germany, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean number of catheter related blood stream infections CRBSI/1'000 catheter days in each group (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826526, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.