[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492978":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":36,"locations":44,"responsibleParty":245,"collaborators":247,"id":251,"slug":252,"hasResults":253,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":253,"sex":259,"minAge":260,"maxAge":24,"enrollmentInfo":261,"targetDuration":24,"studyType":264,"phases":265,"briefSummary":267,"conditions":268,"keywords":24,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":287},{"fullName":5,"class":6},"Major Extremity Trauma Research Consortium","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care PO (oral) antibiotics","ACTIVE_COMPARATOR","An intervention in this study includes randomization of patients with an infected unhealed fracture to standard of care PO (oral) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their oral antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and\u002For resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard.",[13],"Drug: Standard of Care PO (oral) antibiotics",{"label":15,"type":10,"description":16,"interventionNames":17},"Standard of Care Intravenous (IV) antibiotics","An intervention in this study includes randomization of patients with an infected unhealed fracture to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. No medications will be provided by the study. Study participants will be prescribed their IV antibiotics by their treating physician and the specific type will depend on their infection diagnosis. Medications will be obtained using health insurance and\u002For resources available at the treating facility therefore the mode of antibiotics utilized as standard of care will vary across participating sites. Sites will follow their standard of care delivery for antibiotics, and the study will defer to this standard.",[18],"Drug: Standard of Care Intravenous (IV) antibiotics",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","An intervention in this study includes randomization of patients with an infected nonunion to PO (oral) antibiotics for up to 6 weeks post hospitalization. The exact type of oral antibiotic will be depended on the patient's infection diagnosis.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"An intervention in this study includes randomization of patients with an infected nonunion to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. The exact type of IV antibiotic will be depended on the patient's infection diagnosis.",[15],[29,33],{"name":30,"affiliation":31,"role":32},"William Obremskey, MD","Vanderbilt Medical Center","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":32},"Renan Castillo, PhD","Johns Hopkins Bloomberg School of Public Health",[37,41],{"name":30,"role":38,"phone":39,"phoneExt":24,"email":40},"CONTACT","615-260-2054","william.obremskey@vumc.org",{"name":42,"role":38,"phone":24,"phoneExt":24,"email":43},"Karen Trochez","karen.m.trochez@vumc.org",[45,65,81,91,108,121,137,152,168,184,196,213,229],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Indiana University","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.15804,39.76838,{"lat":57,"lon":56},[60,63],{"name":61,"role":38,"phone":24,"phoneExt":24,"email":62},"Lauren Hill, BS","hilllc@iu.edu",{"name":64,"role":32,"phone":24,"phoneExt":24,"email":24},"Roman Natoli, MD",{"facility":66,"status":47,"city":67,"state":68,"zip":69,"country":51,"countryCode":52,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of Maryland , MD Department of Orthopaedics","Baltimore","Maryland","21201",{"type":54,"coordinates":71},[72,73],-76.61219,39.29038,{"lat":73,"lon":72},[76,79],{"name":77,"role":38,"phone":24,"phoneExt":24,"email":78},"Yasmin Degani, MPH","ydegani@som.umaryland.edu",{"name":80,"role":32,"phone":24,"phoneExt":24,"email":24},"Robert O'Toole, MD",{"facility":82,"status":83,"city":67,"state":68,"zip":84,"country":51,"countryCode":52,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Sinai Hospital Baltimore","NOT_YET_RECRUITING","21215",{"type":54,"coordinates":86},[72,73],{"lat":73,"lon":72},[89],{"name":90,"role":32,"phone":24,"phoneExt":24,"email":24},"Janet Conway, MD",{"facility":92,"status":47,"city":93,"state":94,"zip":95,"country":51,"countryCode":52,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Hennepin Health","Minneapolis","Minnesota","55487",{"type":54,"coordinates":97},[98,99],-93.26384,44.97997,{"lat":99,"lon":98},[102,106],{"name":103,"role":38,"phone":104,"phoneExt":24,"email":105},"Olutayo Alese","612-873-4634","olutayo.alese@hcmed.org",{"name":107,"role":32,"phone":24,"phoneExt":24,"email":24},"Andrew Schmidt, MD",{"facility":109,"status":83,"city":110,"state":111,"zip":112,"country":51,"countryCode":52,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Jamaica Hospital Medical Center","Queens","New York","11418",{"type":54,"coordinates":114},[115,116],-73.83652,40.68149,{"lat":116,"lon":115},[119],{"name":120,"role":32,"phone":24,"phoneExt":24,"email":24},"Sanjit Konda, MD",{"facility":122,"status":83,"city":123,"state":124,"zip":125,"country":51,"countryCode":52,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Atrium Health, Carolinas Medical Center","Charlotte","North Carolina","28207",{"type":54,"coordinates":127},[128,129],-80.84313,35.22709,{"lat":129,"lon":128},[132,135],{"name":133,"role":38,"phone":24,"phoneExt":24,"email":134},"Christine Churchill","christine.churchill@atriumhealth.org",{"name":136,"role":32,"phone":24,"phoneExt":24,"email":24},"Madhav Karunakar, MD",{"facility":138,"status":47,"city":139,"state":124,"zip":140,"country":51,"countryCode":52,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Wake Forest University Baptist Medical Center","Winston-Salem","27106",{"type":54,"coordinates":142},[143,144],-80.24422,36.09986,{"lat":144,"lon":143},[147,150],{"name":148,"role":38,"phone":24,"phoneExt":24,"email":149},"Martha Holden","mholden@wakehealth.edu",{"name":151,"role":32,"phone":24,"phoneExt":24,"email":24},"Sharon Babock, MD",{"facility":153,"status":83,"city":154,"state":155,"zip":156,"country":51,"countryCode":52,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"University of Okalahoma College of Medicine","Oklahoma City","Oklahoma","73104",{"type":54,"coordinates":158},[159,160],-97.51643,35.46756,{"lat":160,"lon":159},[163,166],{"name":164,"role":38,"phone":24,"phoneExt":24,"email":165},"Kathy Edge","Kathy-Edge@ou.edu",{"name":167,"role":32,"phone":24,"phoneExt":24,"email":24},"Brandon Hull, MD",{"facility":169,"status":47,"city":170,"state":171,"zip":172,"country":51,"countryCode":52,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"Penn State University M.S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":54,"coordinates":174},[175,176],-76.65025,40.28592,{"lat":176,"lon":175},[179,182],{"name":180,"role":38,"phone":24,"phoneExt":24,"email":181},"Andrea Myers, BSN","amyers1@pennstatehealth.psu.edu",{"name":183,"role":32,"phone":24,"phoneExt":24,"email":24},"J. Spence Reid, MD",{"facility":31,"status":47,"city":185,"state":186,"zip":187,"country":51,"countryCode":52,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Nashville","Tennessee","37203",{"type":54,"coordinates":189},[190,191],-86.78444,36.16589,{"lat":191,"lon":190},[194,195],{"name":42,"role":38,"phone":24,"phoneExt":24,"email":43},{"name":30,"role":32,"phone":24,"phoneExt":24,"email":24},{"facility":197,"status":83,"city":198,"state":199,"zip":200,"country":51,"countryCode":52,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"University of Texas Health Science Center at Houston","Houston","Texas","77030",{"type":54,"coordinates":202},[203,204],-95.36327,29.76328,{"lat":204,"lon":203},[207,211],{"name":208,"role":38,"phone":209,"phoneExt":24,"email":210},"Sterling Boutte","713-500-6259","Sterling.Boutte@uth.tmc.edu",{"name":212,"role":32,"phone":24,"phoneExt":24,"email":24},"Warner Stephen, MD",{"facility":214,"status":47,"city":215,"state":216,"zip":217,"country":51,"countryCode":52,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"University of Washington Harborview Medical Center","Seattle","Washington","98195",{"type":54,"coordinates":219},[220,221],-122.33207,47.60621,{"lat":221,"lon":220},[224,227],{"name":225,"role":38,"phone":24,"phoneExt":24,"email":226},"Jessica Schisel","jrod24@uw.edu",{"name":228,"role":32,"phone":24,"phoneExt":24,"email":24},"Michael Githens, MD",{"facility":230,"status":47,"city":231,"state":232,"zip":233,"country":51,"countryCode":52,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"University of Wisconsin","Madison","Wisconsin","53705",{"type":54,"coordinates":235},[236,237],-89.40123,43.07305,{"lat":237,"lon":236},[240,243],{"name":241,"role":38,"phone":24,"phoneExt":24,"email":242},"Brittany Grasso","otrc@ortho.wisc.edu",{"name":244,"role":32,"phone":24,"phoneExt":24,"email":24},"Paul Whiting, MD",{"type":246,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[248],{"name":249,"class":250},"United States Department of Defense","FED","100492978","phase-3-po-vs-iv-antibiotics-for-the-treatment-of-infected-nonunion-of-fractures-after-fixation-100492978",false,"NCT05699174","PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","POvIV2","Inclusion Criteria:\n\n1. 1\\. Bone fracture (proximal to and including the tarsal\u002Fmetatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.\n2. Infection as determined by either\n\n   1. FRI criteria\n   2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon\n3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks\n\nExclusion Criteria:\n\n1. Patients with a high risk of amputation based on the initial managing physician\n2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment\n3. Incarcerated or institutionalized patients\n4. Patients who are unable to return for required follow-up visits and\u002For medical co-morbidities which preclude treatment with a general anesthetic\n5. Patients with a prior history of chronic infection at the index site before fracture fixation\n6. Patients with pathological fractures from a neoplastic process\n7. History of Paget's Disease\n8. The patient, or a designated proxy, unwilling to provide consent\n9. The patient must be available for follow-up for at least 12 months following infection treatment","ALL","18 Years",{"count":262,"type":263},250,"ESTIMATED","INTERVENTIONAL",[266],"PHASE3","This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.",[269,270,271,272,273,274,275,276,277],"Infections","Infected Wound","Nonunion of Fracture","Injury Leg","Amputation","Internal Fixation; Complications, Infection or Inflammation","Fracture","Lower Extremity Fracture","Antibiotic Side Effect","2026-06-09",{"date":280,"type":281},"2026-06-11","ACTUAL",{"date":283,"type":281},"2023-05-30",{"date":285,"type":263},"2028-09-29",{"name":5,"class":6},13]