Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-01 @ 7:18 PM
Study NCT ID:
NCT00037050
Status:
COMPLETED
Last Update Posted:
2009-09-14
First Post:
2002-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Austria', 'Belgium', 'Brazil', 'Chile', 'Colombia', 'Czechia', 'France', 'Germany', 'Greece', 'Guatemala', 'Hungary', 'India', 'Ireland', 'Italy', 'Mexico', 'Pakistan', 'Panama', 'Peru', 'Philippines', 'Poland', 'Portugal', 'Russia', 'Slovakia', 'South Africa', 'Spain', 'Thailand', 'Turkey (Türkiye)', 'United States', 'Venezuela']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'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': 'D000069349', 'term': 'Linezolid'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D010068', 'term': 'Oxacillin'}, {'id': 'D004009', 'term': 'Dicloxacillin'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003023', 'term': 'Cloxacillin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 739}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-11', 'studyFirstSubmitDate': '2002-05-14', 'studyFirstSubmitQcDate': '2002-05-14', 'lastUpdatePostDateStruct': {'date': '2009-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The empiric treatment of patients with complicated skin and skin structure infections (cSSSI) related to an indwelling catheter;'}, {'measure': 'The empiric treatment of patients with gram-positive catheter-related bloodstream infections.'}], 'secondaryOutcomes': [{'measure': 'Clinical efficacy of linezolid compared to vancomycin/oxacillin/dicloxacillin.2.Incidence of late metastatic sequelae associated with S. aureus infections in patients treated with linezolid'}]}, 'conditionsModule': {'conditions': ['Bacterial Infections', 'Gram-Positive Bacterial Infections', 'Bacteremia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101503.htm', 'label': 'Link to FDA Alert'}]}, 'descriptionModule': {'briefSummary': 'This study will treat patients who have a short term central catheter that is thought to be infected with a specific bacteria (gram positive bacteria)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a central indwelling catheter with signs and symptoms of infection\n\nExclusion Criteria:\n\n* Patients with tunneled catheter which cannot be removed.\n* Patients with evidence of endovascular infection including endocarditis.\n* Patients with infection of permanent intravascular devices.\n* Patients who have received more than 1 day of another antibiotic before enrollment.\n* Patients with HIV and low CD4 count.'}, 'identificationModule': {'nctId': 'NCT00037050', 'briefTitle': 'Antibiotic Treatment for Infections of Short Term In-dwelling Vascular Catheters Due to Gram Positive Bacteria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Linezolid vs. Vancomycin/Oxacillin/Dicloxacillin in the Treatment of Catheter-Related Gram-Positive Bloodstream Infections', 'orgStudyIdInfo': {'id': 'M12600080'}, 'secondaryIdInfos': [{'id': 'A5951060'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox']}, {'name': 'Vancomycin', 'type': 'DRUG'}, {'name': 'Oxacillin', 'type': 'DRUG'}, {'name': 'Dicloxacillin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}