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NCT Number: NCT05781295

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

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.

Recruiting

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Key information

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armand Trousseau, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TaurolockTM

Device

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.

Physiological serum

Device

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 outcomes

  1. Comparison of the incidence of catheter-related infection per 1000 catheter days.

    Time frame: 1000 catheter days

    Comparison of the incidence of catheter-related infection per 1000 catheter days.

Secondary outcomes

  1. Incidence of catheter colonizations.

    Time frame: through study completion, an average of 56 months

    Incidence of catheter colonizations.

  2. Catheter removal time related to catheter complication.

    Time frame: through study completion, an average of 56 months

    Catheter removal time related to catheter complication.

  3. Incidence of catheter removal related to catheter complication.

    Time frame: through study completion, an average of 56 months

    Incidence of catheter removal related to catheter complication.

  4. Incidence of local infections (with or without bacteremia).

    Time frame: through study completion, an average of 56 months

    Incidence of local infections (with or without bacteremia).

  5. Incidence of catheter occlusions.

    Time frame: through study completion, an average of 56 months

    Incidence of catheter occlusions.

  6. Incidence of thrombotic complications.

    Time frame: through study completion, an average of 56 months

    Incidence of thrombotic complications.

  7. Number and hospitalization duration related to catheter complications.

    Time frame: through study completion, an average of 56 months

    Number and hospitalization duration related to catheter complications.

  8. Number and frequency of adverse events linked to lock.

    Time frame: through study completion, an average of 56 months

    Number and frequency of adverse events linked to lock.

  9. 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

    Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Camille CORDERO, MD

CONTACT

[email protected]

+33172389309

Marie-Emmanuelle Legrier, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study 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.

Acronym: PEDIALOCK

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 23, 2023
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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