Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 4:45 AM
Study NCT ID:
NCT00401960
Status:
TERMINATED
Last Update Posted:
2017-05-03
First Post:
2006-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004697', 'term': 'Endocarditis, Bacterial'}, {'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D053821', 'term': 'Cardiovascular Infections'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017576', 'term': 'Daptomycin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kyr9001@med.cornell.edu', 'phone': '6469626224', 'title': 'K Rhee', 'organization': 'Weill Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'study terminated due to insufficient enrollment; data therefore not analyzed'}}, 'adverseEventsModule': {'timeFrame': '2 years; however, study terminated due to lack of eligible study participants', 'eventGroups': [{'id': 'EG000', 'title': 'Adjunctive Daptomycin Group', 'description': 'please see study description for study enrollment', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Standard of Care Group', 'description': 'as per study description', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'hemopericardium', 'notes': 'underlying rheumatic heart disease and congestive heart failure; underlying conduction disorder S/P pacemekaer; both deemed unrelated to antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'death', 'notes': 'uncontrolled progression of underlying CLL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cr elevation', 'notes': 'day 9 of combination ABX with ampicillin, gentamicin, daptomycin- possibly related to daptomycin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'death', 'notes': 'nosocomial Serratia pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Adjunctive Daptomycin Group', 'description': 'please see study description for study enrollment'}, {'id': 'OG001', 'title': 'Standard of Care Group', 'description': 'as per study description'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'weekly', 'description': 'Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study terminated due to insufficient enrollment; therefore data not sufficient for planned analysis'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daptomycin Adjunctive Group', 'description': 'Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving\n\nDaptomycin: daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician'}], 'classes': [{'title': 'Elevated serum creatinine >= 30% above baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Elevate serum creatine kinase > 3X ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'weekly', 'description': 'Number of Participants with creatine kinase elevation \\> 3x upper limit of normal or elevations of serum Cr \\>= 30% above baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'study terminated due to inadequate enrollment; therefore data not sufficient for planned analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adjunctive Daptomycin Group', 'description': 'please see study description for study enrollment'}, {'id': 'FG001', 'title': 'Standard of Care Group', 'description': 'as per study description'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Adjunctive Daptomycin Group', 'description': 'please see study description for study enrollment'}, {'id': 'BG001', 'title': 'Standard of Care Group', 'description': 'as per study description'}, {'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': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '88'}, {'value': '74', 'groupId': 'BG001', 'lowerLimit': '74', 'upperLimit': '74'}, {'value': '70', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'see study inclusion criteria'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'inadequate enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2006-11-20', 'resultsFirstSubmitDate': '2016-12-29', 'studyFirstSubmitQcDate': '2006-11-20', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-06', 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)', 'timeFrame': 'weekly', 'description': 'Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details'}, {'measure': 'Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria', 'timeFrame': 'weekly', 'description': 'Number of Participants with creatine kinase elevation \\> 3x upper limit of normal or elevations of serum Cr \\>= 30% above baseline'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Enterococcus', 'Daptomycin', 'Endocarditis'], 'conditions': ['Endocarditis, Bacterial']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the safety and efficacy of daptomycin when used as an adjuvant agent to standard care in the treatment of proven native valve Enterococcal endocarditis. Patients with this disease will be offered the option of receiving daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving. The hypothesis of this study is that daptomycin added to standard therapy for Enterococcal endocarditis is safe and efficacious.\n\nPatients who receive daptomycin + standard therapy will be compared to patients who receive standard therapy alone with respect to the following outcomes:\n\n1. Safety.\n\n 1. The frequency of any Grade 3 or 4 toxicity (DAIDS scale) will be measured.\n 2. The frequency of muscle toxicity or renal toxicity, as determined by predefined criteria.\n2. Efficacy.\n\n 1. Clinical efficacy.\n\n * Time to clearance of bacteremia\n * Cure at 6 weeks following completion of antibiotic therapy\n * Mortality at 6 weeks following completion of antibiotic therapy\n 2. Microbiologic efficacy.\n\n * Peak and trough serum bactericidal titers\n * The minimum bactericidal concentration of Enterococci to daptomycin\n\nWe expect to enroll 40 patients over 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 or over\n* Definite Enterococcal endocarditis, as defined by modified Duke criteria\n* Able to complete follow-up 3 and 6 weeks following completion of intravenous antibiotic therapy\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding\n* Creatine phosphokinase levels over two times the upper limit of normal\n* Renal insufficiency or dialysis requirement.\n* Presence of chronic indwelling bloodstream catheters or foreign body devices suspected as primary or secondary sites of enterococcal infection unamenable to removal or replacement\n* Inability to discontinue or abstain from use of a HMG CoA reductase inhibitor during the study period.\n* Hypersensitivity to any of the study medications.\n* Any condition that, in the investigator's opinion, may interfere with protocol compliance including, but not limited to, active substance abuse and/or dementia.\n* Prosthetic valve endocarditis"}, 'identificationModule': {'nctId': 'NCT00401960', 'briefTitle': 'Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Open Label Study to Assess the Efficacy and Safety of Daptomycin in Combination With Anti-Cell Wall Active Therapy in the Treatment of Enterococcal Endocarditis', 'orgStudyIdInfo': {'id': '0507008023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daptomycin adjunctive group', 'description': 'Patients with enterococcal endocarditis who elect to receive daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving', 'interventionNames': ['Drug: Daptomycin']}, {'type': 'NO_INTERVENTION', 'label': 'standard of care', 'description': 'Patients with enterococcal endocarditis who elect to receive standard of care therapy as prescribed by their primary physician'}], 'interventions': [{'name': 'Daptomycin', 'type': 'DRUG', 'otherNames': ['Cubicin'], 'description': 'daptomycin at a dose of 8 milligrams/kilogram/day in addition to the antibiotics they are already receiving for native valve enterococcal endocarditis', 'armGroupLabels': ['Daptomycin adjunctive group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Hospital, Weill Cornell Campus', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Kyu Y Rhee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This was a pilot single arm study, for which IPD are not pertinent'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rhee, Kyu Y.', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}