Actively Recruiting
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.
Led by Institut Curie · Updated on 2026-02-20
148
Participants Needed
5
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research investigates the use of a Taurolidine lock compared to a standard saline lock to prevent catheter-related infections in children and young adults undergoing cancer treatment. It is a multicenter, randomized, double-blind study aiming to evaluate the primary prevention of catheter-related endoluminal infections in pediatric oncology patients. Participants will be randomly assigned to receive either Taurolock1212 (Taurolidine lock) or physiological serum (normal saline) injected into their central catheter each time it is used. The study follows patients for up to six months after randomization, monitoring the effects of these two catheter lock solutions. During the study, patients will be followed according to their pathology and treatment protocol. Researchers will track infection rates, catheter colonizations, removals due to complications, local infections, occlusions, thrombotic issues, adverse events related to the locks, and the types of microbes found in cultures. The main outcome is the incidence of catheter-related infection measured per 1000 catheter days. Follow-up assessments will continue for an average of 56 months to gather comprehensive safety and effectiveness data.
CONDITIONS
Brief Title
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient less than or equal to 21 years of age at inclusion.
- Patient planned for central catheter insertion, excluding non-tunneled femoral or cervical external catheters and PICC lines.
- Patient treated for cancer.
- Patient has regular follow-up at the inclusion center.
- Signed informed consent by patient if adult or legal representatives if minor.
- Patient has social security coverage.
- Time between catheter placement and first lock injection less than 6 weeks.
You will not qualify if you...
- Patient with retinoblastoma.
- Allografted patient.
- Patient with life expectancy less than 6 months.
- Patient refusing to participate.
- Patient already receiving a catheter infection prevention lock.
- Patient allergic to citrate or Taurolidine.
- Patient taking drugs contraindicated with citrate or Taurolidine.
- Patient with external femoral catheter.
- Patient with PICC line central catheter.
- Patient unable to follow medical protocol due to geographical, social, or psychological reasons.
- Patient under guardianship or curatorship.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months after randomization
Participants receive either a Taurolock™ or a standard saline lock injected each time their catheter is used as part of their cancer treatment protocol.
Visits occur each time the catheter is accessed for treatment
Duration - Up to approximately 56 months through study completion
Participants are followed for catheter-related outcomes and complications including infections, occlusions, and adverse events linked to the lock.
Ongoing assessments depending on catheter use and clinical follow-up
Trial Site Locations
Total: 5 locations
1
Institut Curie
Paris, France, 75005
Actively Recruiting
2
Saint Louis
Paris, France, 75010
Actively Recruiting
3
Armand Trousseau
Paris, France, 75012
Actively Recruiting
4
Robert Debre
Paris, France, 75935
Actively Recruiting
5
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
C
Camille CORDERO, MD
M
Marie-Emmanuelle Legrier, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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