BacteremiaPhase 3NCT00735813
Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia
A Phase 3 study testing Taurolock and Heparin in people with Bacteremia and Neoplasms, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Bacteremia, Neoplasms
- What is being tested?
- Taurolock and Heparin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2008to Sep 2012
- Phase
- Phase 3
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 0-17 years with malignant disease requiring a tunneled central venous catheter.
Who cannot join
- No written consent from child or parents
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby
Århus N, 8200
About this study
Official title: A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.
Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.
Read the detailed description
The most frequent complications of long term TCVC are catheter related blood steam infections(CRBSI)often caused by microorganisms located in the biofilm formed on the inner surface of the TCVC after a short time. CRBSI may be lifethreatening, will need long term intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic lock therapy. In spite of this CRBSI may often lead to the premature removal of the TCVC.
Several methods to prevent the occurrence of intraluminal microbial colonization have been investigated with no single method standing out as the optimal one.
There is a need for a simple and safe method of reducing the occurrence of CRBSI in immunocompromised children receiving chemotherapy for malignant diseases. Various catheter lock solutions in stead of using heparin have been investigated in experimental models. Taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity in vitro. It is claimed to prevent the formation of luminal biofilm in TCVCs in a CVC model and it has been demonstrated to eradicate infected CVC in a three reports with a total of 18 patients.
In a 24 months study of routine use of Taurolidine 1,25%/Sodium-Citrate 4% (TaurolockTM) a reduction of gram-positive CVC associated infections was demonstrated. The findings were not statistically significant due to relatively few patients.
There is a need of a larger study with more patients receiving Taurolock for locking the TCVC between use in order to test for a significant reduction of the occurrence of CRBSI. Furthermore there is a need for an in vivo demonstration of the reduction of biofilm formation in TCVCs locked with taurolock compared with TCVCs locked with heparin.
- Conditions
- Bacteremia, Neoplasms
- Being tested
- Taurolock, Heparin
- Keywords
- Catheterization, Central, Catheterization, Peripheral, Infection, Methods, Sepsis, Microscopy, Electron, Scanning, Sonication, Taurolidine, Catheters, Indwelling, Pediatrics
- Medical subject headings
- Bacteremia, Neoplasms, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolockDevice
When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.
HeparinDevice
When not in use the childrens tunneled central venous catheters are locked with heparin
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Tunneled central venous catheters locked with Taurolock Receives: Device: Taurolock |
| B | Active comparator | Tunneled central venous catheter locked with heparin Receives: Device: Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group
Measured: November 2010
Secondary outcomes (1)
Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin
Measured: February 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Child Cancer Foundation, TauroPharm
- Responsible party
- Principal investigator, Mette Møller Handrup, Aarhus University Hospital
- Investigators
- Henrik Schrøder, MD, Dr.med., Study director, Aarhus Universityhospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735813
- Sponsor's protocol ID
- 17344
- Status last verified
- Sep 2012
- First submitted
- 14 Aug 2008
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradshaw JH, Puntis JW. Taurolidine and catheter-related bloodstream infection: a systematic review of the literature. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):179-86. doi: 10.1097/MPG.0b013e318162c428.
PubMed 18664870Betjes MG, van Agteren M. Prevention of dialysis catheter-related sepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial Transplant. 2004 Jun;19(6):1546-51. doi: 10.1093/ndt/gfh014. Epub 2004 Feb 19.
PubMed 14993498Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
PubMed 17897607O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007.
PubMed 12517020Raad I, Hanna HA, Alakech B, Chatzinikolaou I, Johnson MM, Tarrand J. Differential time to positivity: a useful method for diagnosing catheter-related bloodstream infections. Ann Intern Med. 2004 Jan 6;140(1):18-25. doi: 10.7326/0003-4819-140-1-200401060-00007.
PubMed 14706968Handrup MM, Moller JK, Schroder H. Central venous catheters and catheter locks in children with cancer: a prospective randomized trial of taurolidine versus heparin. Pediatr Blood Cancer. 2013 Aug;60(8):1292-8. doi: 10.1002/pbc.24482. Epub 2013 Feb 15.
PubMed 23417891
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases.
- ClinicalTrials.gov ID
- NCT00735813
- Acronym / sponsor ID
- 17344
- Conditions
- Bacteremia, Neoplasms
- Keywords
- Catheterization, Central, Catheterization, Peripheral, Infection, Methods, Sepsis, Microscopy, Electron, Scanning, Sonication, Taurolidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Danish Child Cancer Foundation, TauroPharm
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 Aug 2008 (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.
Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.
Detailed description
The most frequent complications of long term TCVC are catheter related blood steam infections(CRBSI)often caused by microorganisms located in the biofilm formed on the inner surface of the TCVC after a short time. CRBSI may be lifethreatening, will need long term intravenous broad spectrum antibiotic therapy possibly combined with intraluminal antibiotic lock therapy. In spite of this CRBSI may often lead to the premature removal of the TCVC.
Several methods to prevent the occurrence of intraluminal microbial colonization have been investigated with no single method standing out as the optimal one.
There is a need for a simple and safe method of reducing the occurrence of CRBSI in immunocompromised children receiving chemotherapy for malignant diseases. Various catheter lock solutions in stead of using heparin have been investigated in experimental models. Taurolidine is a chemically modified amino acid with broad spectrum antimicrobial activity in vitro. It is claimed to prevent the formation of luminal biofilm in TCVCs in a CVC model and it has been demonstrated to eradicate infected CVC in a three reports with a total of 18 patients.
In a 24 months study of routine use of Taurolidine 1,25%/Sodium-Citrate 4% (TaurolockTM) a reduction of gram-positive CVC associated infections was demonstrated. The findings were not statistically significant due to relatively few patients.
There is a need of a larger study with more patients receiving Taurolock for locking the TCVC between use in order to test for a significant reduction of the occurrence of CRBSI. Furthermore there is a need for an in vivo demonstration of the reduction of biofilm formation in TCVCs locked with taurolock compared with TCVCs locked with heparin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: TaurolockTunneled central venous catheters locked with Taurolock |
| B | Active comparator | Device: HeparinTunneled central venous catheter locked with heparin |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 0-17 years with malignant disease requiring a tunneled central venous catheter.
Key exclusion criteria (1 listed)
- No written consent from child or parents
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 |
|---|---|---|
| TaurolockWhen not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin. | Device | A |
| HeparinWhen not in use the childrens tunneled central venous catheters are locked with heparin | Device | B |
Primary outcome
Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group
Time frame: November 2010
1 secondary outcome
Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin
Time frame: February 2010
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 5 Sep 2012.
- Background: PubMed 18664870Bradshaw JH, Puntis JW. Taurolidine and catheter-related bloodstream infection: a systematic review of the literature. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):179-86. doi: 10.1097/MPG.0b013e318162c428.
- Background: PubMed 14993498Betjes MG, van Agteren M. Prevention of dialysis catheter-related sepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial Transplant. 2004 Jun;19(6):1546-51. doi: 10.1093/ndt/gfh014. Epub 2004 Feb 19.
- Background: PubMed 17897607Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
- Background: PubMed 12517020O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007.
- Background: PubMed 14706968Raad I, Hanna HA, Alakech B, Chatzinikolaou I, Johnson MM, Tarrand J. Differential time to positivity: a useful method for diagnosing catheter-related bloodstream infections. Ann Intern Med. 2004 Jan 6;140(1):18-25. doi: 10.7326/0003-4819-140-1-200401060-00007.
- Derived from this study: PubMed 23417891Handrup MM, Moller JK, Schroder H. Central venous catheters and catheter locks in children with cancer: a prospective randomized trial of taurolidine versus heparin. Pediatr Blood Cancer. 2013 Aug;60(8):1292-8. doi: 10.1002/pbc.24482. Epub 2013 Feb 15.
- Related InfoLink provided by the sponsor.
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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.
Henrik Schrøder, MD, Dr.med. study director
Aarhus Universityhospital, Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Taurolock and Heparin in people with Bacteremia and Neoplasms, run by Aarhus University Hospital 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 1 inclusion and 1 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 5 Sep 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group (time frame: November 2010). 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 NCT00735813, which also lists 6 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 5 Sep 2012.