Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-02 @ 6:43 PM
Study NCT ID:
NCT00057369
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C469289', 'term': 'dalbavancin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-02'}, 'statusVerifiedDate': '2003-06', 'completionDateStruct': {'date': '2003-06'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2003-03-31', 'studyFirstSubmitQcDate': '2003-04-01', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Bacteremia']}, 'referencesModule': {'references': [{'pmid': '34905144', 'type': 'DERIVED', 'citation': 'Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* The patient or his/her legally authorized representative has given informed consent by means approved by the investigator's IRB/EC;\n* \\> 18 years of age;\n* Had one or more central venous catheters at the time initial signs of infection were evident;\n* Creatinine clearance \\<50 mL/min;\n* Bilirubin \\> 2x the upper limit of normal;\n* Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation,\n* Prolonged antibiotic therapy for CR-BSI anticipated (i.e., \\>2 weeks)"}, 'identificationModule': {'nctId': 'NCT00057369', 'briefTitle': 'Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vicuron Pharmaceuticals'}, 'officialTitle': 'Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections With Suspected or Confirmed Gram-Positive Bacterial Pathogens', 'orgStudyIdInfo': {'id': 'VER001-4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'dalbavancin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Wellstar/Kennestone Hospital', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vicuron Pharmaceuticals', 'class': 'INDUSTRY'}}}}