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Recruiting NCT05781295

Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology

No phase Interventional Children Medical Device Primary Prevention Oncology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TaurolockTM, Physiological serum.
Who it may be relevant to
Registry conditions: Children, Medical Device, Primary Prevention, Oncology. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.

Overview

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.

Detailed description

The patient will be followed according to the type of pathology and the respective treatment protocol either Taurolock or physiological serum at each time cathter will be used.

Interventions

  • Device TaurolockTM
    The patient will be followed up to a maximum of 6 months after randomization after have a TaurolockTM injected each time catheter will be used.
  • Device Physiological serum
    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.

Primary outcome measures

  • Comparison of the incidence of catheter-related infection per 1000 catheter days. [Time frame: 1000 catheter days]
Secondary outcome measures (9)
  • Incidence of catheter colonizations. [Time frame: through study completion, an average of 56 months]
  • Catheter removal time related to catheter complication. [Time frame: through study completion, an average of 56 months]
  • Incidence of catheter removal related to catheter complication. [Time frame: through study completion, an average of 56 months]
  • Incidence of local infections (with or without bacteremia). [Time frame: through study completion, an average of 56 months]
  • Incidence of catheter occlusions. [Time frame: through study completion, an average of 56 months]
  • Incidence of thrombotic complications. [Time frame: through study completion, an average of 56 months]
  • Number and hospitalization duration related to catheter complications. [Time frame: through study completion, an average of 56 months]
  • Number and frequency of adverse events linked to lock. [Time frame: through study completion, an average of 56 months]
  • Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection. [Time frame: through study completion, an average of 56 months]

Eligibility criteria

Inclusion criteria

  • Patient less than or equal to 21 years of age at inclusion.
  • 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).
  • Patient treated for a cancer.
  • Patient with regular follow-up in the inclusion center.
  • Informed consent signed by the patient if adult or by legal representatives if minor.
  • Patient benefiting from a social security coverage.
  • Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.

Exclusion criteria

  • Patient with retinoblastoma.
  • Allografted patient.
  • Patient with a life expectancy of less than 6 months.
  • Patient refusing to participate in the protocol.
  • Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
  • Patient with known allergy to citrate or (cyclo)-Taurolidine.
  • Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
  • Patient with an external femoral catheter.
  • Patient with a PICCLINE-type peripheral venous inserted central catheter.
  • Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
  • Patient under guardianship and curatorship.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

France · 5 centers
  • Institut Curie — Paris
  • Saint Louis — Paris
  • Armand Trousseau — Paris
  • Robert Debre — Paris
  • Gustave Roussy — Villejuif

Identifiers

NCT: NCT05781295 · IC 2017-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗