Catheter Related Blood Stream InfectionsNCT06660641
Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream Infections
A study testing TaurolockTMHep100 and 0.9 % saline in people with Catheter Related Blood Stream Infections and Intestinal Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Related Blood Stream Infections, Intestinal Failure
- What is being tested?
- TaurolockTMHep100 and 0.9 % saline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jun 2019to 28 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving HPS at the department of Medical gastroenterology, Rigshospitalet, who have at least one prior CRBSI and thereby demonstrated susceptibility towards developing CRBSI while on HPS and the following:
- Signed informed consent form
- Has a single-lumen subcutaneously tunneled CVC
- Has been at least 3 weeks since termination of the antibiotic treatment for their last CRBSI
Who cannot join
- Patients who:
- have a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients
- are pregnant, lactating or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TaurolockTMHep100 Versus Saline 0.9% As Secondary Prevention of Catheter-related Bloodstream Infections (CRBSI); a Single Center, Double Blinded, Randomized, Controlled Study in Patients with Chronic Intestinal Failure Dependent on Home Parenteral Support (HPS)
The purpose of the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support.
Read the detailed description
Patients with long-term intestinal failure rely on Home Parenteral support (HPS) delivered through a central venous catheter(CVC). Catheter Related Blood Stream Infections(CRBSI) are a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of the CVC. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.
The primary objective is to compare two catheter lock solutions, 1,35% taurolidine and 0.9% saline, on the occurence of recurrent CRBSIs. The secondary objectives are to compare the two devices according to other catheter-related complications, adverse events and costs.
Patients with at least one prior CRBSI is included. Patients instill the solution in their CVC after each infusion of HPS, with a minimum of three times per week, depending on their individual HPS programme.
Before the blinded randomization the patients will be paired according to age and stratified according to prior CRBSI incidence.
Duration of the instillation will be 24 months.
- Being tested
- TaurolockTMHep100, 0.9 % saline
- Keywords
- Taurolidine, Catheter-related bloodstream infections, Intestinal failure
- Medical subject headings
- Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolockTMHep100Device
1.35% taurolidine containing catheter losk solution
0.9 % salineDevice
placebo
| Study group | Role | What they receive |
|---|---|---|
| TaurolockTMHep100 | Active comparator | Not described Receives: Device: TaurolockTMHep100 |
| 0.9% saline | Placebo comparator | Not described Receives: Device: 0.9 % saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent catheter-related bloodstream infections
Measured: Treatment time 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start3 Jun 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Catheter Related Blood Stream InfectionsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TauroPharm
- Responsible party
- Principal investigator, Palle Bekker Jeppesen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660641
- Sponsor's protocol ID
- H-19000051
- Status last verified
- Apr 2019
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nerstrom CT, Scheike T, Moser CE, Tribler S, Jeppesen PB. Cost-effectiveness of Taurolidine as secondary prevention of recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: Findings from a randomized controlled trial. Clin Nutr. 2026 Jul;62:106694. doi: 10.1016/j.clnu.2026.106694. Epub 2026 May 22.
PubMed 42235100Nerstrom CT, Scheike T, Moser CE, Tribler S, Jeppesen PB. Taurolidine lock reduces recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: A randomized, placebo-controlled trial in a real-world clinical setting. Clin Nutr. 2025 Aug;51:90-100. doi: 10.1016/j.clnu.2025.05.020. Epub 2025 Jun 3.
PubMed 40554263
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TaurolockTMHep100 Versus Saline 0.9% As Secondary Prevention of Catheter-related Bloodstream Infections (CRBSI); a Single Center, Double Blinded, Randomized, Controlled Study in Patients with Chronic Intestinal Failure Dependent on Home Parenteral Support (HPS)
- ClinicalTrials.gov ID
- NCT06660641
- Acronym / sponsor ID
- H-19000051
- Keywords
- Taurolidine, Catheter-related bloodstream infections, Intestinal failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TauroPharm
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Oct 2024 (actual)
- 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 the trial is to compare two catheter lock solutions (active: 1.35% taurolidine and placebo: 0.9% saline), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous catheter for home parenteral support.
Detailed description
Patients with long-term intestinal failure rely on Home Parenteral support (HPS) delivered through a central venous catheter(CVC). Catheter Related Blood Stream Infections(CRBSI) are a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of the CVC. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.
The primary objective is to compare two catheter lock solutions, 1,35% taurolidine and 0.9% saline, on the occurence of recurrent CRBSIs. The secondary objectives are to compare the two devices according to other catheter-related complications, adverse events and costs.
Patients with at least one prior CRBSI is included. Patients instill the solution in their CVC after each infusion of HPS, with a minimum of three times per week, depending on their individual HPS programme.
Before the blinded randomization the patients will be paired according to age and stratified according to prior CRBSI incidence.
Duration of the instillation will be 24 months.
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 |
|---|---|---|
| TaurolockTMHep100 | Active comparator | Device: TaurolockTMHep100 |
| 0.9% saline | Placebo comparator | Device: 0.9 % saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients receiving HPS at the department of Medical gastroenterology, Rigshospitalet, who have at least one prior CRBSI and thereby demonstrated susceptibility towards developing CRBSI while on HPS and the following:
- Signed informed consent form
- Has a single-lumen subcutaneously tunneled CVC
- Has been at least 3 weeks since termination of the antibiotic treatment for their last CRBSI
Key exclusion criteria (3 listed)
- have a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients
- are pregnant, lactating or nursing
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 |
|---|---|---|
| TaurolockTMHep1001.35% taurolidine containing catheter losk solution | Device | TaurolockTMHep100 |
| 0.9 % salineplacebo | Device | 0.9% saline |
Primary outcome
Incidence of recurrent catheter-related bloodstream infections
Time frame: Treatment time 2 years
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 28 Oct 2024.
- Derived from this study: PubMed 42235100Nerstrom CT, Scheike T, Moser CE, Tribler S, Jeppesen PB. Cost-effectiveness of Taurolidine as secondary prevention of recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: Findings from a randomized controlled trial. Clin Nutr. 2026 Jul;62:106694. doi: 10.1016/j.clnu.2026.106694. Epub 2026 May 22.
- Derived from this study: PubMed 40554263Nerstrom CT, Scheike T, Moser CE, Tribler S, Jeppesen PB. Taurolidine lock reduces recurrent catheter-related bloodstream infections in patients with chronic intestinal failure: A randomized, placebo-controlled trial in a real-world clinical setting. Clin Nutr. 2025 Aug;51:90-100. doi: 10.1016/j.clnu.2025.05.020. Epub 2025 Jun 3.
- Individual participant dataSharing planned: No
Related trials for Catheter Related Blood Stream Infections
Not yet recruiting
The IVCare Adaptive Platform Trial
Device Related Infection, Vascular Access Complication
Not yet recruiting
Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial
Vascular Access Complication, Device Related Infection
Recruiting
Hydrogen Peroxide and Ultraviolet Light for Disinfecting Surfaces in Intensive Care Units
Infection, Hospital, Antimicrobial
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaurolockTMHep100 and 0.9 % saline in people with Catheter Related Blood Stream Infections and Intestinal Failure, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 3 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 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Incidence of recurrent catheter-related bloodstream infections (time frame: Treatment time 2 years). 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 NCT06660641, which also lists 2 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 28 Oct 2024.