ChildrenPEDIALOCKNCT05781295
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
A study testing TaurolockTM and Physiological serum in people with Children and Medical Device, run by Institut Curie at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Children, Medical Device, Primary Prevention
- What is being tested?
- TaurolockTM and Physiological serum
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 5 sitesFrance
- Study dates
- 19 Jan 2024to 23 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Emmanuelle Legrier, PhD contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Institut Curie
Paris, 75005
Lauriane LEMELLE, MD, lauriane.lemelle@curie.fr
Lauriane LEMELLE, MD
- Recruiting
Saint Louis
Paris, 75010
Florence RABIAN, MD, florence.rabian@aphp.fr
Florence RABIAN, MD
- Recruiting
Armand Trousseau
Paris, 75012
Arnaud PETIT, MD, arnaud.petit@aphp.fr
Arnaud PETIT, MD
- Recruiting
Robert Debre
Paris, 75935
Benoit BRETHON, MD, benoit.brethon@aphp.fr
Benoit BRETHON, MD
- Recruiting
Gustave Roussy
Villejuif, 94805
Charlotte RIGAUD, MD, charlotte.rigaud@gustaveroussy.fr
Charlotte RIGAUD, MD
About this study
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.
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.
Read the 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.
- Conditions
- Children, Medical Device, Primary Prevention, Oncology
- Being tested
- TaurolockTM, Physiological serum
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaurolockTMDevice
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 serumDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TauroLock™ | Experimental | 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. Receives: Device: TaurolockTM |
| Physiological serum (NaCl 0.9%) | Placebo comparator | 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. Receives: Device: Physiological serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the incidence of catheter-related infection per 1000 catheter days.
Comparison of the incidence of catheter-related infection per 1000 catheter days.
Measured: 1000 catheter days
Secondary outcomes (9)
Incidence of catheter colonizations.
Incidence of catheter colonizations.
Measured: through study completion, an average of 56 months
Catheter removal time related to catheter complication.
Catheter removal time related to catheter complication.
Measured: through study completion, an average of 56 months
Incidence of catheter removal related to catheter complication.
Incidence of catheter removal related to catheter complication.
Measured: through study completion, an average of 56 months
Incidence of local infections (with or without bacteremia).
Incidence of local infections (with or without bacteremia).
Measured: through study completion, an average of 56 months
Incidence of catheter occlusions.
Incidence of catheter occlusions.
Measured: through study completion, an average of 56 months
Incidence of thrombotic complications.
Incidence of thrombotic complications.
Measured: through study completion, an average of 56 months
Number and hospitalization duration related to catheter complications.
Number and hospitalization duration related to catheter complications.
Measured: through study completion, an average of 56 months
Number and frequency of adverse events linked to lock.
Number and frequency of adverse events linked to lock.
Measured: 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.
Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection.
Measured: through study completion, an average of 56 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start19 Jan 2024
- Primary completion23 Jul 2028 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille CORDERO, MD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781295
- Sponsor's protocol ID
- IC 2017-12
- Acronym
- PEDIALOCK
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2023
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05781295
- Acronym / sponsor ID
- PEDIALOCK / IC 2017-12
- Conditions
- Children, Medical Device, Primary Prevention, Oncology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 23 Jul 2028 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TauroLock™ | Experimental | Device: TaurolockTMThe patient will be followed up to a maximum of 6 months after randomization after have a Taurlock™ injected each time catheter will be used. |
| Physiological serum (NaCl 0.9%) | Placebo comparator | Device: Physiological serumThe 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TaurolockTMThe 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 | TauroLock™ |
| Physiological serumThe 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 (NaCl 0.9%) |
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Emmanuelle Legrier, PhD contact
Camille CORDERO, MD study director
Institut Curie
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaurolockTM and Physiological serum in people with Children and Medical Device, run by Institut Curie at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camille CORDERO, MD (+33172389309, camille.cordero@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the incidence of catheter-related infection per 1000 catheter days. (time frame: 1000 catheter days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.