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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-19

Study Completion Date

2028-07-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.

NCT05740150

Central Line-associated Bloodstream Infection (CLABSI)

UNKNOWN NA

Taurolidine Lock Solution in the Prevention of Catheter Related Bacteremia

NCT00735813

Bacteremia Neoplasms

COMPLETED PHASE3

ATAPAC Study (TauroLock Activity in Adult Cancer Patients)

NCT02279121

Catheter-Related Infections

COMPLETED NA

Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition

NCT02255318

Cancer Infection

UNKNOWN NA

Clinical Trial Comparing TaurolockTMHep100 (Taurolidine 1.35%) and 0.9% Saline As Prevention of Recurrent Catheter-related Bloodstream Infections

NCT06660641

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Children Medical Device Primary Prevention Oncology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

TaurolockTM

Intervention Type 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 (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.

Group Type PLACEBO_COMPARATOR

Physiological serum

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No