Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-04 @ 1:01 PM
Study NCT ID:
NCT03806166
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2019-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short or Long Antibiotic Regimes in Orthopaedics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010019', 'term': 'Osteomyelitis'}, {'id': 'D017719', 'term': 'Diabetic Foot'}], 'ancestors': [{'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016523', 'term': 'Foot Ulcer'}, {'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Ascertainment of the primary outcome (treatment failure) will be undertaken by an independent committee of specialists, using redacted participant clinical records, who will remain unaware of the treatment allocation of the participant, and who will ascertain treatment failure according to established objective criteria.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Non-inferiority randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2019-01-11', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Definitive treatment failure (infection recurrence)', 'timeFrame': '12 months from the time of surgery for bone or joint infection', 'description': 'Proportion of participants in each treatment group experiencing definitive treatment failure (infection recurrence), ascertained by an independent committee of experts unaware of the treatment allocation of the participant, according to established criteria.'}], 'secondaryOutcomes': [{'measure': 'Possible or probable treatment failure', 'timeFrame': '12 months from the time of surgery for bone or joint infection', 'description': 'Proportion of participants in each treatment group experiencing clinical features suggesting possible or probable infection recurrence, not meeting the definition for definitive treatment failure, determined by an independent committee of experts unaware of treatment allocation, where microbiological culture is not done or is negative. Ascertainment is based on established clinical criteria associated with, but not diagnostic of, orthopaedic infection.'}, {'measure': 'Serious Adverse Events', 'timeFrame': '12 months from the time of surgery for bone or joint infection', 'description': 'Proportion of participants in each treatment group experiencing Serious Adverse Events including mortality'}, {'measure': 'Antibiotic side effects', 'timeFrame': 'This will be assessed at baseline (pre-randomisation, at <7 days of treatment), 6 weeks and 3 months from the time of surgery for bone or joint infection', 'description': 'Proportion of participants in each treatment group experiencing possible side-effects from systemic antibiotic treatment, adjusted for severity on a 3-point scale'}, {'measure': 'Quality of life measured by EuroQol 5 Dimensions 5 Levels Score and EuroQol Visual Analogue Score', 'timeFrame': 'At baseline and 12 months from the time of surgery for bone or joint infection', 'description': 'EQ-5D-5L score distribution across 5 dimensions (mobility, self-care, ability to complete usual activities, pain or discomfort, anxiety or depression) for participants, ranging from 1 (worst) to 5 (best) for each dimension. EQ-VAS score distribution for participants, for self-reported health state, ranging from 0 (worst) to 100 (best).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteomyelitis', 'Prosthetic Joint Infection', 'Diabetic Foot']}, 'referencesModule': {'references': [{'pmid': '31815653', 'type': 'DERIVED', 'citation': 'Dudareva M, Kumin M, Vach W, Kaier K, Ferguson J, McNally M, Scarborough M. Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy. Trials. 2019 Dec 9;20(1):693. doi: 10.1186/s13063-019-3832-3.'}]}, 'descriptionModule': {'briefSummary': "Research question: If adults with bone or joint infection have local antibiotic therapy, can they do without prolonged treatment with antibiotics by mouth (oral) or injection?\n\nAdults with bone or joint infections are usually given long courses of oral antibiotics or into a vein (intravenous) following surgery. It is also safe to give antibiotics directly into the bone or joint at the time of surgery: this is called local antibiotic therapy. This study investigates whether using local antibiotic therapy would allow shorter courses of oral or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost.\n\nThis study compares short against long courses of oral or intravenous antibiotics for adults who have been given appropriate local antibiotic therapy to treat bone or joint infection. Patients who can take part will be randomly divided into two groups within 7 days of surgery. One group will stop oral or intravenous antibiotics, while the other group will continue for 4 weeks or more (standard treatment).\n\nAdults with bone and joint infections who have already had surgery and local antibiotic therapy will be invited. Patients will not take part if they need intravenous antibiotics for another reason, or if their infection is caused by bacteria resistant to the antibiotic(s) used in their local antibiotic therapy.\n\nMain measurement: how many patients' infections return within 12 months after surgery. This will be decided by a group of doctors who do not know what treatment the patient received.\n\nOther important measurements: serious adverse events; side-effects; quality of life; cost of treatment.\n\nPatients will be asked questions at their usual clinic visits, and will be given a questionnaire at the start of treatment and 1 year later.", 'detailedDescription': "Using antibiotics wisely, only when and where they are really needed, is important to prevent superbugs emerging. At the moment, bone and joint infections are usually treated by a combination of surgery and antibiotics. Traditionally, treatment relies on several weeks of antibiotics as tablets or injections (systemic antibiotics), but these can sometimes cause problems.\n\nIt is now possible to administer local antibiotics at the time of surgery directly to the site of infection. This allows much higher levels of the antibiotic to be delivered, for days or weeks, following surgery. Therefore, this study will investigate whether local antibiotics with a shorter course of systemic antibiotics can treat bone and joint infections as effectively as local antibiotics with a prolonged course of systemic antibiotics (usual treatment). If so, it may be possible to reduce antibiotic side effects, help to prevent antibiotic resistant bacteria emerging and limit overall treatment costs.\n\nPatients who agree to participate in this study will be allocated at random to two treatment strategies after surgery for bone and joint infection.\n\nOne group of patients will be treated with local antibiotics and a long course of systemic antibiotics, which is the usual treatment: this is the 'long group'.\n\nThe other group will be treated with local antibiotics and a short course of systemic antibiotics: this is the 'short group' whose treatment differs from the current usual treatment.\n\nPatients will be involved in the study for one year, and infection recurrence will be assessed at the time of routine clinic review up to 12 months after surgery. Whether or not treatment has been successful will be assessed by an independent committee of specialists, who will remain unaware of the patient's allocated treatment strategy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of informed consent\n2. Aged 18 years or over\n3. Presenting with an orthopaedic infection, defined by one or more of the following criteria:\n\n 1. localised pain, OR\n 2. localised erythema, OR\n 3. temperature ≥ 38.0 C, OR\n 4. a discharging sinus or wound\n4. Undergoing surgical treatment for the infection\n5. Locally administered antibiotic(s) at the site of orthopaedic infection\n6. Has received \\<= 7 days of systemic antimicrobial therapy after surgery\n7. Would ordinarily be managed with a prolonged course (\\>= 4 weeks) of systemic antibiotic(s)\n8. Specimens for microbiological analysis taken at index surgery\n\nExclusion Criteria:\n\nSurgical exclusion criteria\n\n1. The index operation was not a definitive procedure with the aim of eradicating infection:\n\n 1. Primary closure has not been achieved, or\n 2. Re-look surgery is planned\n2. The index operation involved implant retention (e.g. DAIR)\n\n Microbiological exclusion criteria\n3. Any identified micro-organisms from operative specimens from the site of incident infection are fully resistant to the local antibiotic(s) administered at the site of infection\n\n Medical exclusion criteria\n4. Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis\n5. If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection'}, 'identificationModule': {'nctId': 'NCT03806166', 'acronym': 'SOLARIO', 'briefTitle': 'Short or Long Antibiotic Regimes in Orthopaedics', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial', 'orgStudyIdInfo': {'id': 'IRAS No. 244229'}, 'secondaryIdInfos': [{'id': 'PID 13859', 'type': 'OTHER', 'domain': 'Oxford University Hospitals NHS Foundation Trust'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shorter Systemic Antibiotics', 'description': 'Participants will receive local antibiotic therapy at the time of surgery, followed by one week or less of systemic antibiotic therapy, for bone and joint infection.', 'interventionNames': ['Other: Shorter Systemic Antibiotics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Long Systemic Antibiotics', 'description': 'Participants will receive local antibiotic therapy at the time of surgery, followed by four weeks or more of systemic antibiotic therapy (standard treatment recommended by international guidelines), for bone and joint infection.', 'interventionNames': ['Other: Standard treatment']}], 'interventions': [{'name': 'Shorter Systemic Antibiotics', 'type': 'OTHER', 'description': 'Reduced duration of post-operative systemic antibiotic therapy', 'armGroupLabels': ['Shorter Systemic Antibiotics']}, {'name': 'Standard treatment', 'type': 'OTHER', 'description': 'Standard duration of systemic antibiotic treatment', 'armGroupLabels': ['Long Systemic Antibiotics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'city': 'Porto', 'country': 'Portugal', 'facility': 'Hospital San Antonio', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'BH15 2JB', 'city': 'Poole', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'University Hospitals Dorset', 'geoPoint': {'lat': 50.71429, 'lon': -1.98458}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'WN6 9EP', 'city': 'Wigan', 'state': 'Lancashire', 'country': 'United Kingdom', 'facility': 'Wrightington Hospital', 'geoPoint': {'lat': 53.54296, 'lon': -2.63706}}, {'zip': 'E1 1FR', 'city': 'London', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Barts and the Royal London Hospitals', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'HA7 4LP', 'city': 'Stanmore', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Royal National Orthopaedic Hospital', 'geoPoint': {'lat': 51.61667, 'lon': -0.31667}}, {'zip': 'SY10 7AG', 'city': 'Gobowen', 'state': 'Oswestry', 'country': 'United Kingdom', 'facility': 'The Robert Jones & Agnes Hunt Hospital', 'geoPoint': {'lat': 52.89615, 'lon': -3.03686}}, {'zip': 'OX3 7HE', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Bone Infection Unit, Nuffield Orthopaedic Centre', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'SN3 6BB', 'city': 'Swindon', 'state': 'Wiltshire', 'country': 'United Kingdom', 'facility': 'Great Western Hospital', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'FY3 8NR', 'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Teaching Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BN2 5BE', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Brighton & Sussex University Hospitals NHS Trust', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool Hospitals', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'HA1 3UJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'London North West Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester University NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Northumbria Healthcare NHS Foundation Trust', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'S60 2UD', 'city': 'Rotherham', 'country': 'United Kingdom', 'facility': 'The Rotherham NHS Foundation Trust', 'geoPoint': {'lat': 53.43012, 'lon': -1.35678}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury', 'country': 'United Kingdom', 'facility': 'Salisbury NHS Foundation Trust', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'country': 'United Kingdom', 'facility': 'The Mid Yorkshire Hospitals NHS Trust', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}], 'overallOfficials': [{'name': 'Matthew Scarborough', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator, Consultant in Clinical Infection.', 'investigatorFullName': 'Matthew Scarborough', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}