[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579684":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":38,"collaborators":42,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":59,"studyType":60,"phases":10,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children and adolescents with bone and joint infections treated with initial oral antibiotics",null,"Patients with uncomplicated bone and joint infections treated with initial oral antibiotics.\n\nAccording to Danish Nationwide Guidelines (initiated in 2024), initial oral antibiotics are recommended to patients with no risk factors for complicated disease. Risk factors include for complicated disease include:\n\n1. Severe illness or sepsis\n2. Rapid symptom progression\n3. Pronounced symptoms, including severe pain\n4. Pronounced soft tissue involvement\n5. Foreign material or post-surgical infection\n6. Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA\n7. Severe comorbidity, including immunodeficiency\n\nPatients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included",[13],"Drug: Oral antibiotic treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Oral antibiotic treatment","Initial antibiotics:\n\nBelow 5 years: High-dose amoxicillin-clavulanate (8:1 ratio; 100\u002F12.5 mg\u002Fkg\u002Fday in 3 doses) until clinical improvement and decrease in CRP, followed by dose reduction (4:1 ratio) to 50\u002F12.5 mg\u002Fkg\u002Fday in 3 doses).\n\n5 years and above: High-dose anti-staphylococcal penicillin (200 mg\u002Fkg\u002Fday in 4 doses) until clinical improvement and decrease in CRP, with dose reduction (100 mg\u002Fkg\u002Fday in 4 doses) after clinical improvement\n\nTreatment duration of follow-up therapy (after initial high-dose antibiotics): One week for uncomplicated joint infections, three weeks for bone infections, and four weeks for spondylodiscitis",[9],[21],{"name":22,"affiliation":23,"role":24},"Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil","Copenhagen University Hospital, Rigshospitalet, Denmark","STUDY_CHAIR",[26],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+45 35459761","Ulrikka.Nygaard@regionh.dk",[31],{"facility":32,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":10,"geoPoint":10,"contacts":10},"Rigshospitalet","RECRUITING","Copenhagen Ø","2100","Denmark","DK",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Ulrikka Nygaard","Ass Professor, Consultant, PhD, MD, MPhil",[43],{"name":44,"class":45},"Innovation Fund Denmark","INDIV","100579684","initial-oral-antibiotics-for-bone-and-joint-infections-in-children-100579684",false,"NCT06827496","Initial Oral Antibiotics for Bone and Joint Infections in Children","Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark","Children and adolescents aged 3 months to 17 years with uncomplicated bone and joint infections treated with initial oral antibiotics.\n\nAccording to Danish Nationwide Guidelines (initiated in 2024), initial oral antibiotics are recommended to patients with no risk factors for complicated disease. Risk factors include for complicated disease include:\n\n1. Severe illness or sepsis\n2. Rapid symptom progression\n3. Pronounced symptoms, including severe pain\n4. Pronounced soft tissue involvement\n5. Foreign material or post-surgical infection\n6. Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA\n7. Severe comorbidity, including immunodeficiency\n\nPatients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included","ALL","3 Months","17 Years",{"count":57,"type":58},100,"ESTIMATED","5 Years","OBSERVATIONAL","Initial oral antibiotic treatment for children and adolescents with uncomplicated bone and joint infections (BJI) has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT). The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear.\n\nThis nationwide, prospective, multicenter, real-world cohort study aims to compare the effectiveness and safety of initial oral antibiotic treatment for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.",[63,64,65,66,67],"Osteomyelitis Acute","Septic Arthritis","Bone Infection","Joint Infection","Bone and Joint Infection",[69,70,71,72],"Bone and joint infections","Children","Oral antibiotics","Osteomyelitis","2025-04-05",{"date":75,"type":76},"2025-04-09","ACTUAL",{"date":78,"type":76},"2024-11-15",{"date":80,"type":58},"2027-05",{"name":5,"class":6},1]