Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-03-02 @ 4:00 PM
Study NCT ID:
NCT00548002
Status:
COMPLETED
Last Update Posted:
2007-10-23
First Post:
2007-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D004696', 'term': 'Endocarditis'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080163', 'term': 'trovafloxacin'}, {'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-10-22', 'studyFirstSubmitDate': '2007-10-22', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Case fatality rate', 'timeFrame': 'At 28 days and at 3 months'}], 'secondaryOutcomes': [{'measure': 'The number of complications (e.g. deep infections) observed after the first week antibiotic treatment, decrease in serum C-reactive protein concentration, length of antibiotic treatment, need for surgical intervention, and time to defervescence.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Staphylococcus aureus', 'bacteremia', 'endocarditis', 'sepsis', 'fluoroquinolone', 'rifampin', 'levofloxacin', 'trovafloxacin'], 'conditions': ['Staphylococcus Aureus', 'Bacteremia', 'Endocarditis', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '16420547', 'type': 'RESULT', 'citation': 'Ruotsalainen E, Jarvinen A, Koivula I, Kauma H, Rintala E, Lumio J, Kotilainen P, Vaara M, Nikoskelainen J, Valtonen V; Finlevo Study Group. Levofloxacin does not decrease mortality in Staphylococcus aureus bacteraemia when added to the standard treatment: a prospective and randomized clinical trial of 381 patients. J Intern Med. 2006 Feb;259(2):179-90. doi: 10.1111/j.1365-2796.2005.01598.x.'}, {'pmid': '16965625', 'type': 'RESULT', 'citation': 'Ruotsalainen E, Sammalkorpi K, Laine J, Huotari K, Sarna S, Valtonen V, Jarvinen A. Clinical manifestations and outcome in Staphylococcus aureus endocarditis among injection drug users and nonaddicts: a prospective study of 74 patients. BMC Infect Dis. 2006 Sep 11;6:137. doi: 10.1186/1471-2334-6-137.'}, {'pmid': '21248153', 'type': 'DERIVED', 'citation': 'Grumann D, Ruotsalainen E, Kolata J, Kuusela P, Jarvinen A, Kontinen VP, Broker BM, Holtfreter S. Characterization of infecting strains and superantigen-neutralizing antibodies in Staphylococcus aureus bacteremia. Clin Vaccine Immunol. 2011 Mar;18(3):487-93. doi: 10.1128/CVI.00329-10. Epub 2011 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'To study whether fluoroquinolone (trovafloxacin or levofloxacin), added to standard treatment, could reduce the high mortality and complication rates in Staphylococcus aureus bacteremia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'studyPopulation': 'Adult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients with at least 1 blood culture positive for Staphylococcus aureus were included within 1 to 7 days of blood culture sampling.\n\nExclusion Criteria:\n\n* age younger than 18 years\n* imprisonment\n* proven or suspected pregnancy\n* breastfeeding, epilepsy\n* another bacteremia during the previous 28 days\n* polymicrobial bacteremia (\\_\\>3 microbes)\n* history of allergy to any quinolone antibiotic\n* previous tendinitis during fluoroquinolone therapy\n* prior fluoroquinolone use for more than 5 days before randomization\n* positive culture for Staphylococcus aureus only from a central intravenous catheter\n* neutropenia (\\<0.5 x 109/L) or failure to supply an informed consent\n* patients with bacteremia due to methicillin-resistant S. aureus and a S. aureus strain resistant to any fluoroquinolone\n* patients with meningitis at the time of randomization'}, 'identificationModule': {'nctId': 'NCT00548002', 'acronym': 'FINLEVO', 'briefTitle': 'Combination Therapy With Fluoroquinolone in Staphylococcus Aureus Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'University of Helsinki'}, 'orgStudyIdInfo': {'id': '210275'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1 and 2', 'description': 'Patients were randomly assigned to receive either 1) standard treatment or 2) standard treatment combined with a fluoroquinolone (trovafloxacin or levofloxacin).', 'interventionNames': ['Drug: trovafloxacin and levofloxacin']}], 'interventions': [{'name': 'trovafloxacin and levofloxacin', 'type': 'DRUG', 'description': 'Trovafloxacin: \\<60 kg 200 mg iv/orally once daily and \\>60 kg 300 mg iv/orally once daily Levofloxacin: \\< 60 kg 500 mg iv/orally once daily and \\>60 kg 500 mg iv/orally bid', 'armGroupLabels': ['1 and 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'state': 'HUS', 'country': 'Finland', 'facility': 'Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Eeva Ruotsalainen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Infectious Diseases, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Helsinki', 'class': 'OTHER'}}}}