Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-22 @ 9:23 AM
Study NCT ID:
NCT01524302
Status:
COMPLETED
Last Update Posted:
2016-04-12
First Post:
2012-01-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097583', 'term': 'Ceftaroline'}, {'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'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': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'steing@msu.edu', 'phone': '517-353-5126', 'title': 'Dr. Gary E. Stein', 'organization': 'Michigan State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD'}, {'id': 'OG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'spread': '15', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '5.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD'}, {'id': 'OG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.', 'unitOfMeasure': 'liters per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD'}, {'id': 'OG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD'}, {'id': 'OG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'spread': '23', 'groupId': 'OG000'}, {'value': '90', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.', 'unitOfMeasure': 'mg*hr/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Log Inhibition of 0.5mg/L MIC Levofloxacin', 'description': 'Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline'}, {'id': 'OG001', 'title': 'Log Inhibition of 1.0mg/L MIC Levofloxacin', 'description': 'Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline'}, {'id': 'OG002', 'title': 'Log Inhibition of 2.0mg/L MIC Levofloxacin', 'description': 'Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline'}, {'id': 'OG003', 'title': 'Log Inhibition of 4.0mg/L MIC Levofloxacin', 'description': 'Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline'}], 'classes': [{'title': 'Levofloxacin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Ceftaroline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug', 'description': "Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).\n\nThese staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively.", 'unitOfMeasure': 'Log inhibition', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD'}, {'id': 'FG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Levofloxacin', 'description': 'Pharmacodynamics\n\nLevofloxacin: 750 mg QD'}, {'id': 'BG001', 'title': 'Ceftaroline', 'description': 'Pharmacodynamics\n\nCeftaroline: 600 mg Q12h'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'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': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '72'}, {'value': '52', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '61'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '72'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', '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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-14', 'studyFirstSubmitDate': '2012-01-30', 'resultsFirstSubmitDate': '2015-10-12', 'studyFirstSubmitQcDate': '2012-01-31', 'lastUpdatePostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-14', 'studyFirstPostDateStruct': {'date': '2012-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)', 'timeFrame': '2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug', 'description': "Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth).\n\nThese staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively."}], 'secondaryOutcomes': [{'measure': 'Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.'}, {'measure': 'Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.'}, {'measure': 'Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.'}, {'measure': 'Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.', 'timeFrame': '2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion', 'description': 'To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pneumonia', 'ceftaroline', 'community-aquired'], 'conditions': ['Pneumonia, Bacterial', 'Community-acquired']}, 'descriptionModule': {'briefSummary': 'This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-pregnant adults (≥ 18 years old) with suspected CABP admitted to the hospital for parenteral antibiotic therapy.\n* All patients will have a creatinine clearance (CrCl) \\>50 ml/min.\n\nExclusion Criteria:\n\n* pregnant or nursing patients,\n* allergy to penicillin/cephalosporin antibiotics,\n* allergy to fluoroquinolones,\n* renal or hepatic failure, or have received an antimicrobial in past 96h.\n* Patients who require antibiotics other than the study drugs will also be excluded.'}, 'identificationModule': {'nctId': 'NCT01524302', 'briefTitle': 'Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'Pharmacodynamic of Ceftaroline and Levofloxacin Against Pathogens Associated With Community Acquired Bacterial Pneumonia (CABP)', 'orgStudyIdInfo': {'id': 'TEF-MD-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacin', 'description': 'Pharmacodynamics', 'interventionNames': ['Drug: Levofloxacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ceftaroline', 'description': 'Pharmacodynamics', 'interventionNames': ['Drug: Ceftaroline']}], 'interventions': [{'name': 'Ceftaroline', 'type': 'DRUG', 'otherNames': ['Teflaro'], 'description': '600 mg Q12h', 'armGroupLabels': ['Ceftaroline']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['Levaquin'], 'description': '750 mg QD', 'armGroupLabels': ['Levofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Sparrow Hospital', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}], 'overallOfficials': [{'name': 'Gary E Stein, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gary E. Stein, Pharm.D.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Pharmacology', 'investigatorFullName': 'Gary E. Stein, Pharm.D.', 'investigatorAffiliation': 'Michigan State University'}}}}