Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-06 @ 9:30 PM
Study NCT ID:
NCT05781295
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2023-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-07-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of the incidence of catheter-related infection per 1000 catheter days.', 'timeFrame': '1000 catheter days', 'description': 'Comparison of the incidence of catheter-related infection per 1000 catheter days.'}], 'secondaryOutcomes': [{'measure': 'Incidence of catheter colonizations.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Incidence of catheter colonizations.'}, {'measure': 'Catheter removal time related to catheter complication.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Catheter removal time related to catheter complication.'}, {'measure': 'Incidence of catheter removal related to catheter complication.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Incidence of catheter removal related to catheter complication.'}, {'measure': 'Incidence of local infections (with or without bacteremia).', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Incidence of local infections (with or without bacteremia).'}, {'measure': 'Incidence of catheter occlusions.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Incidence of catheter occlusions.'}, {'measure': 'Incidence of thrombotic complications.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Incidence of thrombotic complications.'}, {'measure': 'Number and hospitalization duration related to catheter complications.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Number and hospitalization duration related to catheter complications.'}, {'measure': 'Number and frequency of adverse events linked to lock.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Number and frequency of adverse events linked to lock.'}, {'measure': 'Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection.', 'timeFrame': 'through study completion, an average of 56 months', 'description': 'Identification of microbiologic germs found in the hemocultures and catheter cultures after catheter removal for catheter infection.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children', 'Medical Device', 'Primary Prevention', 'Oncology']}, 'descriptionModule': {'briefSummary': 'Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology.\n\nMulticentric, controlled, randomized and double-blind label study.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient less than or equal to 21 years of age at inclusion.\n2. 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).\n3. Patient treated for a cancer.\n4. Patient with regular follow-up in the inclusion center.\n5. Informed consent signed by the patient if adult or by legal representatives if minor.\n6. Patient benefiting from a social security coverage.\n7. Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.\n\nExclusion Criteria:\n\n1. Patient with retinoblastoma.\n2. Allografted patient.\n3. Patient with a life expectancy of less than 6 months.\n4. Patient refusing to participate in the protocol.\n5. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).\n6. Patient with known allergy to citrate or (cyclo)-Taurolidine.\n7. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.\n8. Patient with an external femoral catheter.\n9. Patient with a PICCLINE-type peripheral venous inserted central catheter.\n10. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.\n11. Patient under guardianship and curatorship.'}, 'identificationModule': {'nctId': 'NCT05781295', 'acronym': 'PEDIALOCK', 'briefTitle': 'Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology', 'organization': {'class': 'OTHER', 'fullName': 'Institut Curie'}, 'officialTitle': 'Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in the Primary Prevention of Catheter-related Endoluminal Infection in Paediatric Oncology.', 'orgStudyIdInfo': {'id': 'IC 2017-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TauroLock™', 'description': '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.', 'interventionNames': ['Device: TaurolockTM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Physiological serum (NaCl 0.9%)', 'description': '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.', 'interventionNames': ['Device: Physiological serum']}], 'interventions': [{'name': 'TaurolockTM', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['TauroLock™']}, {'name': 'Physiological serum', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Physiological serum (NaCl 0.9%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75005', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Camille CORDERO, MD', 'role': 'CONTACT', 'email': 'camille.cordero@curie.fr'}, {'name': 'Camille CORDERO, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florence RABIAN, MD', 'role': 'CONTACT', 'email': 'florence.rabian@aphp.fr'}, {'name': 'Florence RABIAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Arnaud PETIT, MD', 'role': 'CONTACT', 'email': 'arnaud.petit@aphp.fr'}, {'name': 'Arnaud PETIT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Armand Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75935', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit BRETHON, MD', 'role': 'CONTACT', 'email': 'benoit.brethon@aphp.fr'}, {'name': 'Benoit BRETHON, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Robert Debre', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Charlotte RIGAUD, MD', 'role': 'CONTACT', 'email': 'charlotte.rigaud@gustaveroussy.fr'}, {'name': 'Charlotte RIGAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Camille CORDERO', 'role': 'CONTACT', 'email': 'camille.cordero@curie.fr', 'phone': '+33 1 72 38 93 09'}, {'name': 'Marie-Emmanuelle Legrier', 'role': 'CONTACT', 'email': 'marieemmanuelle.legrier@curie.fr'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.', 'ipdSharing': 'YES', 'description': 'Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.', 'accessCriteria': '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).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Curie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}