Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-26 @ 6:41 AM
Study NCT ID:
NCT01037192
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2009-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018461', 'term': 'Soft Tissue Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anna.yuen@fraserhealth.ca', 'phone': '604-520-4005', 'title': 'Anna Yuen, BSc. Pharm', 'organization': 'Fraser Health Authority'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The main limitation was low enrollment, primarily caused by stringent inclusion criteria. The age limitation was required to ensure safe vancomycin administration. The weight limitation was required for medication preparation.'}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'March 1 to September 30, 2010', 'eventGroups': [{'id': 'EG000', 'title': 'Vancomycin Once Daily', 'description': 'Subject receives vancomycin 30 mg/kg dose', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vancomycin Twice Daily', 'description': 'Subject receives vancomycin 15 mg/kg twice daily', 'otherNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'subjects', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin Once Daily', 'description': 'Vancomycin 30 mg/kg IV daily'}, {'id': 'OG001', 'title': 'Vancomycin Twice Daily', 'description': 'Vancomycin 15 mg/kg IV twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'description': 'Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (\\> 15%) in leukocytes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'subjects', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Microbiological Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vancomycin Once Daily', 'description': 'Subject receives vancomycin 30 mg/kg dose'}, {'id': 'OG001', 'title': 'Vancomycin Twice Daily', 'description': 'Subject receives vancomycin 15 mg/kg twice daily'}], 'classes': [{'title': 'Favourable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unfavourable', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'description': 'Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vancomycin Once Daily', 'description': 'Subject receives vancomycin 30 mg/kg dose'}, {'id': 'FG001', 'title': 'Vancomycin Twice Daily', 'description': 'Subject receives vancomycin 15 mg/kg twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from March to September 2010 from patients from the Outpatient Antibiotic Intravenous Therapy clinic at the Royal Columbian Hospital, New Westminster, BC, Canada.', 'preAssignmentDetails': 'Subjects were excluded from the trial based on the inclusion and exclusion criteria. The main reasons for exclusion include age and weight.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vancomycin Once Daily', 'description': 'Subject receives vancomycin 30 mg/kg dose'}, {'id': 'BG001', 'title': 'Vancomycin Twice Daily', 'description': 'Subject receives vancomycin 15 mg/kg twice daily'}, {'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': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '12', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '48', 'spread': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'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': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2009-12-18', 'resultsFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2009-12-18', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-11', 'studyFirstPostDateStruct': {'date': '2009-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Efficacy', 'timeFrame': '5 days', 'description': 'Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (\\> 15%) in leukocytes.'}], 'secondaryOutcomes': [{'measure': 'Microbiological Efficacy', 'timeFrame': '5 days', 'description': 'Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['outpatient', 'skin and soft tissue infections', 'vancomycin intravenous'], 'conditions': ['Skin and Soft Tissue Infections']}, 'referencesModule': {'references': [{'pmid': '11751780', 'type': 'RESULT', 'citation': 'Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60. doi: 10.1093/jac/49.1.155.'}]}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 to 70 years\n* Weight 40 - 80 kg\n* Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated\n* Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician\n* Subject able to provide informed consent\n\nExclusion Criteria:\n\n* Known history of allergy to vancomycin\n* Pregnancy\n* Granulocytopenia (\\< 1x109/L)\n* Renal impairment (serum creatinine \\> 177 µmol/L or eGFR \\< 50 mL/min)\n* Known history of vestibular disease or hearing loss\n* Subjects treated with vancomycin within the previous month\n* Subjects who have received more than 24 hours of vancomycin\n* Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)'}, 'identificationModule': {'nctId': 'NCT01037192', 'acronym': 'VOD', 'briefTitle': 'Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections', 'organization': {'class': 'OTHER', 'fullName': 'Fraser Health'}, 'officialTitle': 'Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections', 'orgStudyIdInfo': {'id': 'VOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vanco once daily', 'description': 'Subject receives vancomycin 30 mg/kg dose', 'interventionNames': ['Drug: vancomycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vanco twice daily', 'description': 'Subject receives vancomycin 15 mg/kg twice daily', 'interventionNames': ['Drug: vancomycin']}], 'interventions': [{'name': 'vancomycin', 'type': 'DRUG', 'description': 'vancomycin 30 mg/kg intravenous administered once daily', 'armGroupLabels': ['Vanco once daily']}, {'name': 'vancomycin', 'type': 'DRUG', 'description': 'vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)', 'armGroupLabels': ['Vanco twice daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3L 3W7', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}], 'overallOfficials': [{'name': 'Anna Yuen, BSc. Pharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fraser Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fraser Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Anna Yuen', 'investigatorAffiliation': 'Fraser Health'}}}}