Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01734694
Status:
TERMINATED
Last Update Posted:
2023-05-03
First Post:
2012-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}, {'id': 'D001170', 'term': 'Arthritis, Infectious'}, {'id': 'D004696', 'term': 'Endocarditis'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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': 'D014640', 'term': 'Vancomycin'}, {'id': 'D000097583', 'term': 'Ceftaroline'}, {'id': 'D017576', 'term': 'Daptomycin'}, {'id': 'D000069349', 'term': 'Linezolid'}], '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': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000081', 'term': 'Acetamides'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JVAZQUEZ@augusta.edu', 'phone': '(706) 723-0105', 'title': 'Jose Vazquez', 'organization': 'Augusta University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vancomycin', 'description': 'Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;', 'otherNumAtRisk': 51, 'otherNumAffected': 0, 'seriousNumAtRisk': 51, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Comparator', 'description': 'Ceftaroline: Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;\n\nDaptomycin: Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h\n\nLinezolid: 600 mg IV/PO q12h', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 16}], 'seriousEvents': [{'term': 'Nephrotoxicity', 'notes': 'Increase in SCr of at least 0.5 mg/dL or 50% (whichever is greater) on at least 2 consecutive measurements while on the study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'notes': 'An abrupt change in renal function signified by an increase in SCr of at least 0.3 mg/dL, a reduction in creatinine clearance (CrCl) of at least 50%, or a change in urine output to \\<0.5 mL/kg/h for at least 6 hours.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Individuals With Nephrotoxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': 'Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Ceftaroline: Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;\n\nDaptomycin: Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h\n\nLinezolid: 600 mg IV/PO q12h'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.', 'description': 'Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.\n\nThis measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': 'Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Ceftaroline: Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;\n\nDaptomycin: Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h\n\nLinezolid: 600 mg IV/PO q12h'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.', 'description': 'An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (\\< 0.5 ml/kg/hr x 6 hrs) while on the study drug.\n\nThis measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Proportion of Individuals With Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin', 'description': 'Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Ceftaroline: Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;\n\nDaptomycin: Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h\n\nLinezolid: 600 mg IV/PO q12h'}], 'classes': [{'categories': [{'title': 'Clinical Success', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Clinical Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Daily assessment of signs and symptoms of infection, and a median of 7 days.', 'description': 'Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.\n\nThis measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vancomycin', 'description': 'Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;'}, {'id': 'FG001', 'title': 'Comparator', 'description': 'Ceftaroline: Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;\n\nDaptomycin: Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h\n\nLinezolid: 600 mg IV/PO q12h'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vancomycin', 'description': 'Vancomycin: Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;'}, {'id': 'BG001', 'title': 'Comparator', 'description': 'Ceftaroline: Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;\n\nDaptomycin: Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h\n\nLinezolid: 600 mg IV/PO q12h'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '51', 'upperLimit': '68'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '68'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Independent biostatistician recommended early termination of the trial due to low probability of success.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-13', 'studyFirstSubmitDate': '2012-11-14', 'resultsFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-13', 'studyFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Individuals With Nephrotoxicity', 'timeFrame': 'Day 1 and daily serum creatinine assessment up to date of discharge from hospital, and a median of 7 days.', 'description': 'Increase in SCr of 0.5 mg/dL or 50% above baseline for at least two consecutive days while on the study drug and through discharge from hospital.\n\nThis measure will be reported as proportion of patients with nephrotoxicity within each group in relation to the number of patients in each group.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Individuals With Acute Kidney Injury Network Modified Definition of Nephrotoxicity', 'timeFrame': 'Day 1 and daily serum creatinine assessment up to date of discharge, and a median of 7 days.', 'description': 'An abrupt (within 48 hour) reduction in kidney function with one or more of the following 1) Increase in SCr ≥ 0.3 mg/dL 2) Increase SCr ≥ 50% or 3) Decreased urine output (\\< 0.5 ml/kg/hr x 6 hrs) while on the study drug.\n\nThis measure will be reported as proportion of patients with acute kidney injury within each group in relation to the number of patients in each group.'}, {'measure': 'Proportion of Individuals With Clinical Success', 'timeFrame': 'Daily assessment of signs and symptoms of infection, and a median of 7 days.', 'description': 'Clinical success is a composite endpoint of those patients with clinical cure or improvement in clinical signs and symptoms of infection (i.e. SIRS criteria, and microbiology) while on the study drug.\n\nThis measure will be reported as the proportion of patients with clinical success in each group compared to the the total number of patients in the group.'}]}, 'conditionsModule': {'conditions': ['Health Care Associated Pneumonia', 'Osteomyelitis/Septic Arthritis', 'Endocarditis', 'Bacteremia', 'Acute Bacterial Skin and Skin Structure Infections']}, 'descriptionModule': {'briefSummary': 'For more than fifty years, vancomycin has been cited as a nephrotoxic agent. Reports of vancomycin induced kidney injury (a.k.a vancomycin induced nephrotoxicity or VIN), have waxed and waned throughout the years for various reasons. Recently, VIN has reemerged as a clinical concern. This may be due to various reasons, including new dosing recommendations as well as an increased prevalence of risk factors associated with vancomycin induced nephrotoxicity. This study aims to evaluate a strategy which attempts to reduce kidney damage from vancomycin use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Receiving intravenous vancomycin for the treatment of healthcare associated pneumonia, osteomyelitis/septic arthritis, endocarditis/bacteremia, or acute bacterial skin and skin structure infections\n* Expected to receive vancomycin for at least 72 hours and are within the first 72 hours of therapy\n* Have at least two or more of the following risk factors for drug-induced nephrotoxicity: a) receipt high-dose vancomycin therapy (greater than or equal to four grams per day) b) receipt of vasopressors c) receipt of nephrotoxic drugs (i.e. aminoglycosides, furosemide, acyclovir, amphotericin b, colistin, and intravenous contrast dye) d) pre-existing renal dysfunction (i.e. SCr greater than or equal to 1.5 mg/dL).\n\nExclusion Criteria:\n\n* Pregnancy\n* End-stage renal disease\n* Receipt of more than 4 grams of vancomycin prior to enrollment on current admission\n* Absolute neutrophil count \\< 1000/mm3'}, 'identificationModule': {'nctId': 'NCT01734694', 'acronym': 'STOP-NT', 'briefTitle': 'Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients', 'orgStudyIdInfo': {'id': '7089'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'interventionNames': ['Drug: Vancomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'interventionNames': ['Drug: Ceftaroline', 'Drug: Daptomycin', 'Drug: Linezolid']}], 'interventions': [{'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;\n\nTarget trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;', 'armGroupLabels': ['Vancomycin']}, {'name': 'Ceftaroline', 'type': 'DRUG', 'otherNames': ['Teflaro'], 'description': 'Dose based on package insert labeling\n\nCrCL \\> 50 mL/min: 600 mg IV q12h\n\nCrCL 31-50 mL/min: 400 mg q12h\n\nCrCL 15-30 mL/min: 300 mg q12h\n\nCrCL \\< 15mL/min: 200 mg q12h;', 'armGroupLabels': ['Comparator']}, {'name': 'Daptomycin', 'type': 'DRUG', 'otherNames': ['Cubicin'], 'description': 'Dose based on renal function and literature dosing recommendations\n\nCrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h\n\nCrCL \\< 30 mL/min: 6 - 10 mg/kg IV q48h', 'armGroupLabels': ['Comparator']}, {'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox'], 'description': '600 mg IV/PO q12h', 'armGroupLabels': ['Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48208', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Jose Vazquez, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Jose Vazquez', 'investigatorAffiliation': 'Henry Ford Health System'}}}}