Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-29 @ 9:47 AM
Study NCT ID:
NCT00974493
Status:
COMPLETED
Last Update Posted:
2020-06-05
First Post:
2009-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'matthew.scarborough@ouh.nhs.uk', 'phone': '07872436461', 'title': 'Matthew Scarborough', 'organization': 'Oxford University Hospitals NHS Trust'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.", 'otherNumAtRisk': 527, 'deathsNumAtRisk': 527, 'otherNumAffected': 80, 'seriousNumAtRisk': 527, 'deathsNumAffected': 6, 'seriousNumAffected': 138}, {'id': 'EG001', 'title': 'Intravenous Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.", 'otherNumAtRisk': 527, 'deathsNumAtRisk': 527, 'otherNumAffected': 86, 'seriousNumAtRisk': 527, 'deathsNumAffected': 17, 'seriousNumAffected': 146}], 'otherEvents': [{'term': 'Related to the operative site', 'notes': 'Includes directed specialist care for symptom control, wound management, mobility, skin and soft tissue infection, dislocation or recurrent primary endpoint', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Antibiotic related', 'notes': 'Antibiotic related events represented here were attributed by the responsible infection specialist to antibiotic therapy (as opposed to unrelated co-morbidities).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Frailty related', 'notes': 'Frailty related events included slips, trips or falls in the elderly or readmission as a result of inability to cope at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'All', 'notes': 'Adverse Event data were not available for 8 participants in relation to C difficile and Line Complication. For events collected by non-systematic methods, data are reported with reference to organ system rather than specific adverse event term', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 146}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'C difficile', 'notes': 'C difficile was reported as a defined secondary outcome. No data available from 4 participants in each arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Line complication', 'notes': 'Line complications were reported as a defined secondary outcome. No data available from 4 participants in each arm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 523, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 523, 'numAffected': 49}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and soft tissue unrelated to original surgical site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 527, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 527, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Frequency of Definite Failure of Infection Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."}, {'id': 'OG001', 'title': 'Intravenous Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT (excluding participants without available endpoint data)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."}, {'id': 'FG001', 'title': 'Intravenous Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '527'}, {'groupId': 'FG001', 'numSubjects': '527'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '509'}, {'groupId': 'FG001', 'numSubjects': '506'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."}, {'id': 'BG001', 'title': 'Intravenous Antibiotics', 'description': "Antibiotics: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '91'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '92'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '92'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '358', 'groupId': 'BG000'}, {'value': '320', 'groupId': 'BG001'}, {'value': '678', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '527', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}, {'value': '527', 'groupId': 'BG001'}, {'value': '1054', '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': 1054}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2009-09-04', 'resultsFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2009-09-09', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-03', 'studyFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Frequency of Definite Failure of Infection Treatment.', 'timeFrame': '1 year', 'description': 'Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oral', 'intravenous', 'antibiotics', 'bone', 'joint', 'infection'], 'conditions': ['Bone Infection', 'Joint Infection']}, 'descriptionModule': {'briefSummary': 'The study will compare the outcomes of treating bone and joint infections with 6 weeks of intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic "strategy" rather than of individual antibiotics. The study will be open label, but the primary outcome will be proven failure of infection treatment, determined by pre-established objective criteria for treatment failure. The null hypothesis tested is that there will be no difference in treatment failure rates.', 'detailedDescription': 'A long course of antibiotic therapy given by a "drip" (i.e. intravenous) is recommended treatment for many serious bacterial infections. It is costly and inconvenient for the patient to remain hospitalised for therapy, so outpatient antibiotic therapy (OPAT) programmes have been established in many countries to deliver intravenous antibiotics safely and conveniently. The majority of patients referred to OPAT programmes have bone and joint infections. However, there is no clear evidence that bone and joint infection really require long courses of intravenous antibiotics rather than oral antibiotics.\n\nWe will compare the outcome of treatment with intravenous versus oral antibiotic therapy for patients with bone and joint infection. The choice of antibiotic is complex, and antibiotics that are suitable oral choices are often not suitable intravenous choices and vice versa. Subjects will therefore be randomized to an oral or intravenous "strategy," rather than to individual antibiotics. Outcomes will be determined by pre-established objective criteria for treatment failure.\n\nWe have conducted a pilot study in one centre (Oxford), recruiting approximately 200 patients, and are now expanding to include multi-centre recruitment in the UK, aiming to recruit 1050 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;\n\n 1. Native osteomyelitis.\n 2. Native joint septic arthritis.\n 3. Diabetic foot infection with osteomyelitis.\n 4. Prosthetic joint associated infection.\n 5. Discitis/ spinal osteomyelitis/ epidural abscess\n* Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already given after definitive surgical management.\n* Has a clinical diagnosis of bacterial infection (caused by any organism excepting mycobacteria).\n* Is clinically stable in the opinion of the study clinicians, has no further interventions to treat acute infection required or planned.\n\nExclusion Criteria:\n\n* Has Staph aureus bacteraemia.\n* Has suspected bacterial endocarditis.\n* Has suspected mediastinal infection.\n* Has suspected central nervous system infection.'}, 'identificationModule': {'nctId': 'NCT00974493', 'acronym': 'OVIVA', 'briefTitle': 'Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study', 'orgStudyIdInfo': {'id': 'OVIVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral antibiotics', 'interventionNames': ['Drug: Antibiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous antibiotics', 'interventionNames': ['Drug: Antibiotics']}], 'interventions': [{'name': 'Antibiotics', 'type': 'DRUG', 'otherNames': ['Individual antibiotics not specified by protocol'], 'description': "The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.\n\nWithin allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.", 'armGroupLabels': ['Intravenous antibiotics', 'Oral antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LD', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Nuffield Orthopaedic Centre', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford Radcliffe Hospitals Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Philip Bejon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford Radcliffe Hospitals Trust'}, {'name': 'Matthew Scarborough, MB BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Matthew Scarborough', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}