Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT02255318
Status:
UNKNOWN
Last Update Posted:
2016-10-28
First Post:
2014-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2014-09-30', 'studyFirstSubmitQcDate': '2014-10-01', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of infections related to chamber implantable catheters (IRCIC) in patients who received Taurolock® versus those who received the usual procedure of saline flush.', 'timeFrame': 'The incidence will be assessed between the inclusion and 3 months after the beginning of the study.', 'description': 'Definition of IRCIC This definition of infections related to chamber implantable catheters will be used for all patients. It is based on the identification of the same germ blood cultures of peripheral vein and those of the central venous line with a differential time greater than 120 minutes growth.'}], 'secondaryOutcomes': [{'measure': 'Delay onset of IRCIC', 'timeFrame': 'between the inclusion and 3 months after the beginning of the study'}, {'measure': 'Duration of hospitalizations for IRCIC.', 'timeFrame': 'between the inclusion and 3 months after the beginning of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Taurolock®', 'infections related to chambers implantable catheter', 'patients with cancer receiving parenteral nutrition'], 'conditions': ['Cancer', 'Infection']}, 'descriptionModule': {'briefSummary': 'The therapeutic management of patients with cancer often requires the establishment of a chamber implantable catheter. Infections are the main complication of these catheters. These infections may be responsible for a significant impairment of quality of life for patients, and may increase the frequency and duration of hospitalizations. The rate of mortality from these infections is about 17%. The objective of this study is to evaluate the efficacy of a 1.35% taurolidine lock / 4% citrate (TauroLock®) in the primary prevention of infections related to chambers implantable catheter (IRCIC) in cancer patients receiving parenteral nutrition.\n\nThis is a, randomized, double-blind clinical trial comparing the incidence of IRCIC in patients receiving Taurolidine lock or concession the usual procedure of rinsing with saline (placebo) (pulsed rinsing with 20 mL of serum physiological and clamping catheter positive pressure). The lock will be instilled after the end of the session IV treatment (chemotherapy, parenteral nutrition, transfusion) before closing the catheter. The primary endpoint will be the rate IRCIC in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years and over\n* Patients with solid cancer\n* Patients with implantable catheter\n* Patients receiving parenteral nutrition\n* Patient affiliated to a social security scheme or beneficiary of such a regime\n\nExclusion Criteria:\n\n* Patients refusing to participate in the protocol\n* Patients already receiving preventive lock of IRCIC\n* Known citrate or (cyclo) allergy -taurolidine\n* Patients taking other drugs with known contraindications against the citrate or cyclotaurolidine.\n* Participation in another protocol for the prevention of infections associated with central venous catheters\n* Patients who did not sign the consent\n* Patient with a status of socio-legal protection'}, 'identificationModule': {'nctId': 'NCT02255318', 'briefTitle': 'Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Primary Prevention of Infections Related to Chambers Implantable Catheter by a Taurolodine Lock in Patients With Cancer Receiving Parenteral Nutrition', 'orgStudyIdInfo': {'id': '2013-792'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Taurolock', 'description': 'Patients received Taurolock lock for 3 months administration.', 'interventionNames': ['Device: Taurolock']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients received placebo lock (physiological serum) for 3 months administration.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Taurolock', 'type': 'DEVICE', 'armGroupLabels': ['Taurolock']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'France', 'state': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Forestier', 'role': 'CONTACT', 'email': 'julien.forestier@chu-lyon.fr'}], 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.60366, 'lon': -0.84802}}, {'city': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marielle GUILLET', 'role': 'CONTACT', 'email': 'marielle.guillet@chu-lyon.fr'}], 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.60366, 'lon': -0.84802}}, {'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion Chauvenet', 'role': 'CONTACT', 'email': 'marion.chauvenet@chu-lyon.fr'}], 'facility': 'Groupement Hospitalier Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Cécile CHAMBRIER, PH', 'role': 'CONTACT', 'email': 'cecile.chambrier@chu-lyon.fr', 'phone': '4.72 00 15 25', 'phoneExt': '+33'}, {'name': 'Isabelle DELFOUR', 'role': 'CONTACT', 'email': 'isabelle.delfour@chu-lyon.fr', 'phone': '4.26.73.27.25', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Cécile CHAMBRIER, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}