[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403801":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":42,"responsibleParty":189,"collaborators":25,"id":191,"slug":192,"hasResults":193,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":193,"sex":198,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":25,"studyType":204,"phases":205,"briefSummary":207,"conditions":208,"keywords":25,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","ACTIVE_COMPARATOR","Children will receive high-dose oral cefalexin 37.5 mg\u002Fkg\u002Fdose (max 1.5 g) QID 1 to 7 days followed by oral cefalexin 45 mg\u002Fkg\u002Fdose (max 1.5 g) TDS for a total course of 3 weeks",[13],"Drug: Oral cefalexin only",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard Therapy","Children will receive IV cefazolin 50 mg\u002Fkg\u002Fdose (max 2 g) three-times daily (TDS) or IV flucloxacillin 50 mg\u002Fkg\u002Fdise (max 2 g) four-times daily (QID) for 1 to 7 days followed by oral cefalexin 45 mg\u002Fkg\u002Fdose (max 1.5 g) three-times daily (TDS) for a total course of 3 weeks",[18],"Drug: IV cefazolin or IV flucloxacillin followed by oral cefalexin",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral cefalexin only","High-dose oral cefalexin",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"IV cefazolin or IV flucloxacillin followed by oral cefalexin","Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin",[15],[31],{"name":32,"affiliation":5,"role":33},"Amanda Gwee, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Alison Boast, MD","CONTACT","+61393455522","alison.boast@gmail.com",{"name":32,"role":37,"phone":38,"phoneExt":25,"email":41},"amanda.gwee@rch.org.au",[43,63,78,92,99,114,129,144,159,174],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Nepean Hospital","RECRUITING","Kingswood","New South Wales","2747","Australia","AU",{"type":52,"coordinates":53},"Point",[54,55],150.72346,-33.75614,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":25,"email":61},"Archana Koirala, Dr","0430112042","archana.koirala@health.nsw.gov.au",{"name":59,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":64,"status":45,"city":65,"state":47,"zip":66,"country":49,"countryCode":50,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"John Hunter Children's Hospital","New Lambton Heights","2305",{"type":52,"coordinates":68},[69,70],151.69364,-32.92466,{"lat":70,"lon":69},[73,77],{"name":74,"role":37,"phone":75,"phoneExt":25,"email":76},"Coen Butters, Dr","+61 2 4291 3000","Coen.Butters@health.nsw.gov.au",{"name":74,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":79,"status":45,"city":80,"state":47,"zip":81,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Sydney Children's Hospital Network","Sydney","2031",{"type":52,"coordinates":83},[84,85],151.20732,-33.86785,{"lat":85,"lon":84},[88],{"name":89,"role":37,"phone":90,"phoneExt":25,"email":91},"Brendan Mcmullan, Dr","293821241","Brendan.Mcmullan@health.nsw.gov.au",{"facility":93,"status":94,"city":80,"state":47,"zip":95,"country":49,"countryCode":50,"cosmosGeoPoint":96,"geoPoint":98,"contacts":25},"The Children's Hospital at Westmead","ACTIVE_NOT_RECRUITING","2145",{"type":52,"coordinates":97},[84,85],{"lat":85,"lon":84},{"facility":100,"status":45,"city":101,"state":102,"zip":103,"country":49,"countryCode":50,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Royal Darwin Hospital","Darwin","Northern Territory","0811",{"type":52,"coordinates":105},[106,107],130.84185,-12.46113,{"lat":107,"lon":106},[110],{"name":111,"role":37,"phone":112,"phoneExt":25,"email":113},"Joshua R Francis","+61423528381","josh.francis@menzies.edu.au",{"facility":115,"status":45,"city":116,"state":117,"zip":118,"country":49,"countryCode":50,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Queensland Children's Hospital","Brisbane","Queensland","4101",{"type":52,"coordinates":120},[121,122],153.02809,-27.46794,{"lat":122,"lon":121},[125],{"name":126,"role":37,"phone":127,"phoneExt":25,"email":128},"Clare Nourse, Prof","0413586954","clare.nourse@health.qld.gov.au",{"facility":130,"status":45,"city":131,"state":132,"zip":133,"country":49,"countryCode":50,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Women's and Children's Hospital","Adelaide","South Australia","5006",{"type":52,"coordinates":135},[136,137],138.59863,-34.92866,{"lat":137,"lon":136},[140],{"name":141,"role":37,"phone":142,"phoneExt":25,"email":143},"Celia M Cooper, Dr","(08)81616396","celia.cooper@sa.gov.au",{"facility":145,"status":45,"city":146,"state":147,"zip":148,"country":49,"countryCode":50,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"The Royal Children's Hospital","Melbourne","Victoria","3051",{"type":52,"coordinates":150},[151,152],144.96332,-37.814,{"lat":152,"lon":151},[155,158],{"name":36,"role":37,"phone":156,"phoneExt":25,"email":157},"+61395699551","alison.boast@rch.org.au",{"name":32,"role":37,"phone":156,"phoneExt":25,"email":41},{"facility":160,"status":45,"city":161,"state":162,"zip":163,"country":49,"countryCode":50,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Perth Children's Hospital","Perth","Western Australia","6009",{"type":52,"coordinates":165},[166,167],115.8614,-31.95224,{"lat":167,"lon":166},[170],{"name":171,"role":37,"phone":172,"phoneExt":25,"email":173},"Asha Bowen, A\u002FProf","08 64562222","asha.bowen@health.wa.gov.au",{"facility":175,"status":45,"city":176,"state":25,"zip":177,"country":178,"countryCode":179,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Christchurch Hospital","Christchurch","8011","New Zealand","NZ",{"type":52,"coordinates":181},[182,183],172.63333,-43.53333,{"lat":183,"lon":182},[186],{"name":187,"role":37,"phone":25,"phoneExt":25,"email":188},"Tony Walls, A\u002FProf","tony.walls@otago.ac.nz",{"type":190,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100403801","phase-4-bone-and-joint-infections---simplifying-treatment-in-children-trial-100403801",false,"NCT04538053","BonE and Joint Infections - Simplifying Treatment in Children Trial","BEST","Inclusion Criteria:\n\n* Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.\n\nExclusion Criteria:\n\n1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)\n2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)\n3. Concomitant severe, invasive infection e.g. necrosing fasciitis\n4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\\>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma)\n5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins\n6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection\n7. Prior episode of OM or SA\n8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)\n9. Prior enrolment in the trial\n10. Current recipient of another investigational product as part of a clinical trial","ALL","1 Year","18 Years",{"count":202,"type":203},285,"ESTIMATED","INTERVENTIONAL",[206],"PHASE4","This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.",[209,210,211,212],"Bone Infection","Septic Arthritis","Bone and Joint Infection","Osteomyelitis","2025-11-14",{"date":215,"type":216},"2025-11-17","ACTUAL",{"date":218,"type":216},"2021-06-01",{"date":220,"type":203},"2026-12",{"name":5,"class":6},10]