[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613450":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":49,"studyPopulation":49,"armGroups":53,"interventions":64,"overallOfficials":49,"centralContacts":72,"locations":78,"responsibleParty":122,"collaborators":124,"id":129,"slug":49,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":49,"enrollmentInfo":138,"targetDuration":49,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":98,"whyStopped":49,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Michael Garron Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Primary Effectiveness Outcomes","Cure (defined by meeting the criteria of: alive, not currently receiving antibiotics, no antibiotic switch from the assigned regimen and no surgical amputation)","24 Weeks",[14,17,20,23,25,27,29,31,33,35],{"measure":15,"description":16,"timeFrame":12},"Secondary Effectiveness Outcomes","The number of participant deaths.",{"measure":15,"description":18,"timeFrame":19},"Proportion of participants with an antibiotic switch (oral or IV)","24 weeks",{"measure":21,"description":22,"timeFrame":19},"Secondary Effectiveness Outcome","Number and level of amputations",{"measure":21,"description":24,"timeFrame":19},"Number of debridement operations",{"measure":21,"description":26,"timeFrame":19},"Proportion of participants receiving chronic antibiotics for infection suppression",{"measure":21,"description":28,"timeFrame":19},"Total duration of antibiotics (oral and IV) for the initial treatment episode",{"measure":21,"description":30,"timeFrame":19},"Number and type of antibiotic-related adverse events",{"measure":21,"description":32,"timeFrame":19},"Quality of life measurement at 24 weeks (determined by EQ-5D questionnaire) The EQ-5D is a standardized instrument for measuring health-related quality of life. Scores range from 0 (worst possible health state) to 1 (best possible health state), with higher scores indicating better",{"measure":21,"description":34,"timeFrame":19},"Wound colonization with a pathogen of interest",{"measure":21,"description":36,"timeFrame":37},"Any positive clinical bacterial culture","52 weeks",[39,42,44],{"measure":40,"description":41,"timeFrame":19},"Feasibility Outcome","The proportion of potentially eligible participants approached for the trial who provide consent and are randomized (recruitment rate)",{"measure":40,"description":43,"timeFrame":19},"The proportion of participants who receive an initial dose of an antibiotic from the class to which they were randomly allocated (adherence rate)",{"measure":40,"description":45,"timeFrame":19},"The proportion of participants from whom the primary effectiveness outcome is obtained (complete outcome ascertainment rate).",{"allocation":47,"interventionModel":48,"interventionModelDescription":49,"primaryPurpose":50,"observationalModel":49,"timePerspective":49,"maskingInfo":51},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":52,"maskingDescription":49,"whoMasked":49},"NONE",[54,59],{"label":55,"type":56,"description":49,"interventionNames":57},"Oral Beta-Lactam Antibiotic","EXPERIMENTAL",[58],"Drug: Oral Beta-Lactam Antibiotic",{"label":60,"type":61,"description":49,"interventionNames":62},"Oral Non-Beta-Lactam Antibiotic","ACTIVE_COMPARATOR",[63],"Drug: Oral Non-Beta-Lactam Antibiotic",[65,69],{"type":66,"name":55,"description":67,"armGroupLabels":68,"otherNames":49},"DRUG","Participants in this arm are randomized to receive an oral antibiotic from the beta-lactam class (e.g., penicillins or cephalosporins) for the treatment of lower extremity osteomyelitis.",[55],{"type":66,"name":60,"description":70,"armGroupLabels":71,"otherNames":49},"Participants in this arm are randomized to receive an oral antibiotic from the non-beta-lactam class (e.g., fluoroquinolones, lincosamides, sulfonamides) for the treatment of lower extremity osteomyelitis.",[60],[73],{"name":74,"role":75,"phone":76,"phoneExt":49,"email":77},"Christopher Kandel, MD","CONTACT","14164696252","christopher.kandel@tehn.ca",[79,97,113],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Ottawa Hospital","NOT_YET_RECRUITING","Ottawa","Ontario","K1Y 4E9","Canada","CA",{"type":88,"coordinates":89},"Point",[90,91],-75.69812,45.41117,{"lat":91,"lon":90},[94],{"name":95,"role":75,"phone":49,"phoneExt":49,"email":96},"Derek MacFadden, MD","dmacfadden@toh.ca",{"facility":5,"status":98,"city":99,"state":83,"zip":100,"country":85,"countryCode":86,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"RECRUITING","Toronto","M4C 3E7",{"type":88,"coordinates":102},[103,104],-79.39864,43.70643,{"lat":104,"lon":103},[107,109],{"name":74,"role":75,"phone":108,"phoneExt":49,"email":77},"4164696252",{"name":110,"role":75,"phone":111,"phoneExt":49,"email":112},"Mazen Almatry, MBA","+16473940003","Mazen.Almatry@tehn.ca",{"facility":114,"status":81,"city":99,"state":83,"zip":115,"country":85,"countryCode":86,"cosmosGeoPoint":116,"geoPoint":118,"contacts":119},"University Health Network","M5G 2C4",{"type":88,"coordinates":117},[103,104],{"lat":104,"lon":103},[120],{"name":49,"role":75,"phone":49,"phoneExt":49,"email":121},"bryan.coburn@uhn.ca",{"type":123,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR",[125,127],{"name":126,"class":6},"University Health Network, Toronto",{"name":128,"class":6},"Ottawa Hospital Research Institute","100613450",false,"NCT07266753","Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot","Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis","OSTEO","Inclusion Criteria:\n\n1. Adult (\\> 18 years old)\n2. OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and\u002For radiographically)\n3. Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment\n4. Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration\n\nExclusion Criteria:\n\n1. Prior enrolment in the OSTEO trial\n2. Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM\n3. No beta-lactam or non-beta-lactam option due to any of:\n\n   1. Allergy\n   2. Suspected or confirmed antimicrobial resistance\n   3. Medical contraindications\n   4. Non-modifiable drug-drug interaction risk\n4. Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin\n5. Prior antibiotic treatment for the same infection in the past 6 months\n6. Known pregnancy, planning to become pregnant during the study period, or breastfeeding","ALL","18 Years",{"count":139,"type":140},1418,"ESTIMATED","INTERVENTIONAL",[143],"PHASE4","The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot. The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. The first step is to assess whether it is possible to perform the trial by determining whether participants can be recruited and followed successfully. If the trial is proven to be possible, it will be expanded to ensure an answer to whether the two antibiotic classes work as well for the treatment of bone infections of the leg and foot.",[146,147,148],"Osteomyelitis of Lower Extremities","Osteomyelitis - Foot","Osteomyelitis of the Foot",[150,151,152,153],"Osteomyelitis","Bone Infection","Lower Extremity","Oral beta-lactams versus non-beta-lactams","2026-03-23",{"date":156,"type":157},"2026-03-27","ACTUAL",{"date":159,"type":157},"2026-02-26",{"date":161,"type":140},"2033-12-31",{"name":5,"class":6},3]