Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-30 @ 2:02 AM
Study NCT ID:
NCT01287832
Status:
TERMINATED
Last Update Posted:
2014-02-10
First Post:
2011-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D013203', 'term': 'Staphylococcal Infections'}], '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'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D017576', 'term': 'Daptomycin'}], 'ancestors': [{'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': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'leonard.johnson@stjohn.org', 'phone': '3133438823', 'title': 'Leonard Johnson MD', 'organization': 'St. John Hospital and Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'High-dose Daptomycin', 'description': 'Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Nephrotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Success at Test of Cure Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)'}, {'id': 'OG001', 'title': 'High-dose Daptomycin', 'description': 'Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30-42 days post-treatment', 'description': 'Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity', 'timeFrame': '30-42 days post-treatment', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)'}, {'id': 'FG001', 'title': 'High-dose Daptomycin', 'description': 'Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Dose Vancomycin', 'description': 'Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)'}, {'id': 'BG001', 'title': 'High-dose Daptomycin', 'description': 'Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '22.6', 'groupId': 'BG000'}, {'value': '68.2', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '64.7', 'spread': '17.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Low patient enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-16', 'studyFirstSubmitDate': '2011-01-31', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-02', 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Success at Test of Cure Visit.', 'timeFrame': '30-42 days post-treatment', 'description': 'Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.'}], 'secondaryOutcomes': [{'measure': 'Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity', 'timeFrame': '30-42 days post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methicillin-resistant', 'Staphylococcus aureus'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Signed informed consent\n* All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature \\< 36.0ยบ C), tachycardia (heart rate \\> 100 beats/minute), hypotension (systolic blood pressure \\< 90 mm Hg) or other clinical features of sepsis.\n* All cases of right-sided native valve endocarditis due to MRSA\n* Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study\n* Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses'}, 'identificationModule': {'nctId': 'NCT01287832', 'briefTitle': 'Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)', 'organization': {'class': 'OTHER', 'fullName': 'St. John Health System, Michigan'}, 'orgStudyIdInfo': {'id': 'SJ1210-01'}, 'secondaryIdInfos': [{'id': 'IND 109,614', 'type': 'OTHER', 'domain': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High dose vancomycin', 'description': 'Vancomycin dosed to achieve a trough of 15-20 microgram/mL.', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose daptomycin', 'description': 'Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)', 'interventionNames': ['Drug: Daptomycin']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Vancomycin dosed to achieve a trough of 15-20 microgram/mL.', 'armGroupLabels': ['High dose vancomycin']}, {'name': 'Daptomycin', 'type': 'DRUG', 'armGroupLabels': ['High-dose daptomycin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. John Health System, Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Henry Ford Health System', 'class': 'OTHER'}, {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Chief', 'investigatorFullName': 'Leonard B. Johnson', 'investigatorAffiliation': 'St. John Health System, Michigan'}}}}