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

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ClinicalTrials.gov Identifier: NCT05781295
Recruitment Status : Recruiting
First Posted : March 23, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Children Medical Device Primary Prevention Oncology Device: TaurolockTM Device: Physiological serum Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.
Actual Study Start Date : January 19, 2024
Estimated Primary Completion Date : July 23, 2028
Estimated Study Completion Date : July 23, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TauroLock™
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.
 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.
Placebo Comparator: Physiological serum (NaCl 0.9%)
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05781295


Contacts
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Contact: Camille CORDERO +33 1 72 38 93 09 camille.cordero@curie.fr
Contact: Cyrine Ezzili +33 1 47 11 16 57 cyrine.ezzili@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75005
Contact: Camille CORDERO, MD       camille.cordero@curie.fr   
Saint Louis Not yet recruiting
Paris, France, 75010
Contact: Florence Rabian       florence.rabian@aphp.fr   
Armand Trousseau Recruiting
Paris, France, 75012
Contact: Fanny ALBY-LAURENT       fanny.alby-laurent@aphp.fr   
Robert Debre Recruiting
Paris, France, 75935
Contact: Benoit Brethon       benoit.brethon@aphp.fr   
Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Charlotte RIGAUD       charlotte.rigaud@gustaveroussy.fr   
Sponsors and Collaborators
Institut Curie
More Information
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT05781295    
Other Study ID Numbers: IC 2017-12 PEDIALOCK
First Posted: March 23, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms