Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-29 @ 1:57 AM
Study NCT ID:
NCT05740150
Status:
UNKNOWN
Last Update Posted:
2023-02-22
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062666', 'term': 'Vascular Access Devices'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 462}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-13', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of central line associated bloodstream infections', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}], 'secondaryOutcomes': [{'measure': 'Time to first central line associated bloodstream infection', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Central line associated bloodstream infection incidence per 1,000 central venous access device-days', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Incidence of symptomatic central venous thrombosis', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Incidence of bacteraemia', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Incidence of local infections', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Dispense of thrombolysis/systemic antibiotic treatment due to central line associated bloodstream infections/ central venous thrombosis', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Incidence of and reasons for central venous access device-removal', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Cultured microorganisms causing central line associated bloodstream infections', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Days of hospital admission due to central line associated bloodstream infections/ central venous thrombosis', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}, {'measure': 'Safety in terms of known side effects, severe adverse events, intensive care unit admission, and mortality rate due to central line associated bloodstream infections/central venous thrombosis', 'timeFrame': 'From central venous access device insertion until the end of follow-up (maximum of 90 days).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Central Line-associated Bloodstream Infection', 'Paediatric oncology patients', 'Central venous access device'], 'conditions': ['Central Line-associated Bloodstream Infection (CLABSI)']}, 'referencesModule': {'references': [{'pmid': '36944461', 'type': 'DERIVED', 'citation': 'van den Bosch CH, Loeffen Y, van der Steeg AFW, van der Bruggen JT, Frakking FNJ, Fiocco M, van de Ven CP, Wijnen MHWA, van de Wetering MD. CATERPILLAR-study protocol: an assessor-blinded randomised controlled trial comparing taurolidine-citrate-heparin to heparin-only lock solutions for the prevention of central line-associated bloodstream infections in paediatric oncology patients. BMJ Open. 2023 Mar 21;13(3):e069760. doi: 10.1136/bmjopen-2022-069760.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this assessor blinded randomized controlled trial is to compare a lock solution containing taurolidine, citrate and heparin to a heparin only lock solution for the prevention of central line associated bloodstream infections in paediatric oncology patients with a central venous access device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 0 - \\<19 years\n* Radiological, cytological or histological proven paediatric malignancy (hematologic, solid, and neurologic malignancies)\n* Tunnelled external central venous access device or totally implantable venous access port to be inserted at the Princess Máxima Center for Pediatric Oncology\n* Planned central venous access device insertion of \\>90 days\n* Written consent signed according to local law and regulations\n* Parents/guardians or patient are willing and able to comply with the trial procedure\n\nExclusion Criteria:\n\n* A previous central venous access device removed \\< 12 months ago.\n* Expected treatment for a majority of the follow-up time in a different hospital than the Princess Maxima Center for pediatric oncology in the first 90 days of inclusion resulting in difficulties/the inability to visit the Princess Maxima Center at least once every 3 weeks.\n* Primary immunological disorder\n* Contra indications: known hypersensitivity to taurolidine, citrate or heparin, and a history of heparin-induced thrombocytopenia.\n* Documented bacteremia in the period from 24h before catheter insertion until inclusion'}, 'identificationModule': {'nctId': 'NCT05740150', 'acronym': 'CATERPILLAR', 'briefTitle': 'Central Line-associated Bloodstream Infection Prevention Using TauroLock-Hep100 in Pediatric Oncology Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Princess Maxima Center for Pediatric Oncology'}, 'officialTitle': 'The Efficacy of a Lock Solution Containing Taurolidine, Citrate and Heparin for the Prevention of Tunneled Central Line-associated Bloodstream Infections in Pediatric Oncology Patients, a Randomized Controlled, Mono-center Trial.', 'orgStudyIdInfo': {'id': 'NL2365.041.26'}, 'secondaryIdInfos': [{'id': 'NTR668', 'type': 'REGISTRY', 'domain': 'Nederlands Trial Register'}, {'id': '12617', 'type': 'OTHER_GRANT', 'domain': 'Dutch Cancer Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)', 'interventionNames': ['Device: TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heparin lock (heparin 100 IU/mL)', 'interventionNames': ['Device: Heparin lock (heparin 100 IU/mL)']}], 'interventions': [{'name': 'TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)', 'type': 'DEVICE', 'description': 'The TauroLock-Hep100 is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.', 'armGroupLabels': ['TauroLock-Hep100 (taurolidine 1.35%, citrate 4%, heparin 100 IU/mL)']}, {'name': 'Heparin lock (heparin 100 IU/mL)', 'type': 'DEVICE', 'description': 'The Heparin lock is a lock solution that is instilled in the lumen of a central venous access device after a treatment cycle.', 'armGroupLabels': ['Heparin lock (heparin 100 IU/mL)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3511XK', 'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ceder van den Bosch, MSc', 'role': 'CONTACT', 'email': 'c.h.vandenbosch-4@prinsesmaximacentrum.nl', 'phone': '+31625395632'}], 'facility': 'Princess Máxima Center for Pediatric Oncology', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Ceder H van den Bosch, MSc', 'role': 'CONTACT', 'email': 'c.h.vandenbosch-4@prinsesmaximacentrum.nl', 'phone': '+31625395632'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Before the end of the study the study protocol, statistical analysis plan and informed consent forms will be published in a peer-reviewed journal. The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.', 'ipdSharing': 'YES', 'description': 'The results of this trial will be published in an open access peer-reviewed journal, presented at international congresses and subsequently the data (stored for at least 15 years) will be made available after publication of the main results manuscript upon reasonable requests. The patient society (Vereniging Kinderkanker Nederland) will be involved in the plan for the dissemination of the trial results to the participants and public after completion of the trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Maxima Center for Pediatric Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Cancer Society', 'class': 'OTHER'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}