Clinical trial · Interventional
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.
NCT05781295CI-TRIAL-00103768PEDIALOCKrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology. Multicentric, controlled, randomized and double-blind label study.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Children | — | UNRESOLVED | — |
| Medical Device | — | UNRESOLVED | — |
| Oncology | — | UNRESOLVED | — |
| Primary Prevention | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physiological serum | Device | — | UNRESOLVED |
| TaurolockTM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TauroLock™
- description
- The patient will be followed up to a maximum of 6 months after randomization after have a Taurlock™ injected each time catheter will be used.
- interventionNames
- Device: TaurolockTM
- type
- PLACEBO_COMPARATOR
- label
- Physiological serum (NaCl 0.9%)
- description
- The patient will be followed up to a maximum of 6 months after randomization after have a Physiological serum injected each time catheter will be used.
- interventionNames
- Device: Physiological serum
Primary outcomes (1)
- measure
- Comparison of the incidence of catheter-related infection per 1000 catheter days.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient less than or equal to 21 years of age at inclusion. 2. Patient for whom a central catheter is planned to be inserted\*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as PICC line). \*1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal). 3. Patient treated for a cancer. 4. Patient with regular follow-up in the inclusion center. 5. Informed consent signed by the patient if adult or by legal representatives if minor. 6. Patient benefiting from a social security coverage. 7. Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks. Exclusion Criteria: 1. Patient with retinoblastoma. 2. Allografted patient. 3. Patient with a life expectancy of less than 6 months. 4. Patient refusing to participate in the protocol. 5. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC). 6. Patient with known allergy to citrate or (cyclo)-Taurolidine. 7. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine. 8. Patient with an external femoral catheter. 9. Patient with a PICCLINE-type peripheral venous inserted central catheter. 10. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons. 11. Patient under guardianship and curatorship.
References
Publications (0)
Data not yet available
No reference posted for this study.