Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-08 @ 4:52 AM
Study NCT ID:
NCT02288234
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telavancin Observational Use Registry (TOUR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C487637', 'term': 'telavancin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1063}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to clinical response', 'timeFrame': '6 months', 'description': 'defined as the number of days between initiation of telavancin therapy and date of cure, where cure is defined as the resolution of the signs and symptoms of infection and/or no need for additional antibiotic therapy, or clearance of the infection with a negative culture result \\[Mohr 2009\\]'}], 'secondaryOutcomes': [{'measure': 'Frequency and Proportion of Patients experiencing Renal Adverse Events (AEs)', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Registry'], 'conditions': ['Hospital Acquired Bacterial Pneumonia', 'Complicated Skin and Skin Structure Infections', 'Ventilator Associated Bacterial Pneumonia', 'Gram Positive Infection']}, 'referencesModule': {'references': [{'pmid': '34041706', 'type': 'DERIVED', 'citation': 'Sims CR, Bressler AM, Graham DR, Lacy MK, Lombardi DA, Castaneda-Ruiz B. Real-World Clinical Use and Outcomes of Telavancin for the Treatment of Bone and Joint Infections: Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2021 Dec;8(4):509-518. doi: 10.1007/s40801-021-00255-6. Epub 2021 May 26.'}, {'pmid': '32372280', 'type': 'DERIVED', 'citation': 'Reilly J, Jacobs MA, Friedman B, Cleveland KO, Lombardi DA, Castaneda-Ruiz B. Clinical Experience with Telavancin for the Treatment of Patients with Bacteremia and Endocarditis: Real-World Results from the Telavancin Observational Use Registry (TOUR). Drugs Real World Outcomes. 2020 Sep;7(3):179-189. doi: 10.1007/s40801-020-00191-x.'}]}, 'descriptionModule': {'briefSummary': 'The telavancin observational use registry (TOUR) will collect data to support study of the efficacy, safety, and pattern of use of telavancin in hospital-based inpatients and in outpatients being treated in infusion centers who are receiving clinician directed telavancin therapy.', 'detailedDescription': 'This is a retrospective medical chart review, multicenter, observational study to examine telavancin efficacy and safety in a real-word setting and to characterize the pattern of use of telavancin in hospital-based inpatients and in outpatient infusion centers. All treatment decisions and clinical assessment will be made at the discretion of the treating physician per usual care and are not mandated by study design or protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will aim to enroll approximately 1,000 patients from 50-60 hospital sites or outpatient infusion centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-received at least 1 dose of telavancin since January 1, 2015\n\nExclusion Criteria:\n\n* Participation in an interventional research study or clinical trial involving telavancin after January 01, 2015'}, 'identificationModule': {'nctId': 'NCT02288234', 'acronym': 'TOUR', 'briefTitle': 'Telavancin Observational Use Registry (TOUR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cumberland Pharmaceuticals'}, 'officialTitle': 'Telavancin Observational Use Registry (TOUR)', 'orgStudyIdInfo': {'id': '0120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vibativ', 'description': 'This is an observational study for patients who were already prescribed Vibativ.', 'interventionNames': ['Drug: Vibativ']}], 'interventions': [{'name': 'Vibativ', 'type': 'DRUG', 'otherNames': ['telavancin'], 'description': 'This is an observational study for patients who were already prescribed Vibativ.', 'armGroupLabels': ['Vibativ']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48075', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Newland Medical Associates', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cumberland Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cumberland Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}