[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493736":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":126,"collaborators":26,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":26,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"University of Sydney","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral fosfomycin","EXPERIMENTAL","* Children who have been diagnosed with an uncomplicated UTI will be administered a single dose of oral fosfomycin trometamol. Then, on Day 2 either;\n\n  1. Stop if the child has clinically improved, or\n  2. Give a second dose of oral fosfomycin trometamol if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or\n  3. Give an additional 8 days of oral fosfomycin trometamol with repeat doses every 48 hours (to make up a total 10-day treatment duration) if the child has evidence of a complicated UTI.\n* Children who have been diagnosed with a complicated UTI will be administered repeat doses of oral fosfomycin trometamol every 48 hours until the child has received a total 10-day course of antibiotics with presumed or proven efficacy against the urinary pathogen.",[13],"Drug: Fosfomycin",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care antibiotics","ACTIVE_COMPARATOR","* Children who have been diagnosed with an uncomplicated UTI will be administered a 3-day course of standard of care (SOC) antibiotics with known efficacy against the urinary pathogen. Then, on Day 3 either;\n\n  1. Stop of the child has clinically improved, or\n  2. Give an additional 48 hours of SOC antibiotics if the child has ongoing fever or clinical symptoms consistent with an uncomplicated UTI, or\n  3. Give an additional 7 days of SOC antibiotics (to make up a total 10-day duration) if the child has evidence of a complicated UTI.\n* Children who have been diagnosed with a complicated UTI will be administered a total 10-day course of SOC antibiotics with known efficacy against the urinary pathogen.",[19],"Drug: Standard of care antibiotics",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fosfomycin","Fosfomycin trometamol is a white crystalline powder which is very soluble in water. The granules are mixed with 90ml of cool water for the constitution to dissolve and will be administered soon after reconstitution. Each 30ml will contain 1g fosfomycin base.\n\n* Children ≥ 6 months to \\\u003C1 year old will be administered 30ml (=1g fosfomycin base) of dissolved solution and the remainder discarded for each dose.\n* Children ≥ 1 to 11 years will be administered 60ml (=2g fosfomycin base) of dissolved solution and the remainder discarded for each dose.\n* Children ≥12 and \\\u003C18 years will be administered the entire 90ml solution (= 3g fosfomycin base) for each dose.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard of care antibiotics","Standard of care antibiotics will be chosen by the treating clinician according to institutional prescribing practices, local antibiograms and medication availability.",[15],[32],{"name":33,"affiliation":5,"role":34},"Phoebe Williams","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Michelle L Harrison","CONTACT","0411900359","m.harrison@sydney.edu.au",[42,65,77,92,109],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Sydney Childrens Hospital","RECRUITING","Sydney","New South Wales","2031","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],151.20732,-33.86785,{"lat":54,"lon":53},[57,61,62],{"name":58,"role":38,"phone":59,"phoneExt":26,"email":60},"Phoebe Williams, Dr","+61411445575","phoebe.williams1@health.nsw.gov.au",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":63,"role":64,"phone":26,"phoneExt":26,"email":26},"Robert Duguid","SUB_INVESTIGATOR",{"facility":66,"status":67,"city":45,"state":46,"zip":68,"country":48,"countryCode":49,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"The Children's Hospital at Westmead","NOT_YET_RECRUITING","2145",{"type":51,"coordinates":70},[53,54],{"lat":54,"lon":53},[73,75],{"name":74,"role":38,"phone":26,"phoneExt":26,"email":26},"Phillip Britton, A\u002FProf",{"name":76,"role":34,"phone":26,"phoneExt":26,"email":26},"Philip Britton",{"facility":78,"status":44,"city":79,"state":80,"zip":81,"country":48,"countryCode":49,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Queensland Children's Hospital","Brisbane","Queensland","4101",{"type":51,"coordinates":83},[84,85],153.02809,-27.46794,{"lat":85,"lon":84},[88,90],{"name":89,"role":38,"phone":26,"phoneExt":26,"email":26},"Adam Irwin, Dr",{"name":91,"role":34,"phone":26,"phoneExt":26,"email":26},"Adam Irwin",{"facility":93,"status":44,"city":94,"state":95,"zip":96,"country":48,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Royal Childrens Hospital","Melbourne","Victoria","3052",{"type":51,"coordinates":98},[99,100],144.96332,-37.814,{"lat":100,"lon":99},[103,107],{"name":104,"role":38,"phone":105,"phoneExt":26,"email":106},"Amanda Gwee, A\u002FProf","+61 3 9345 5522","Amanda.Gwee@rch.org.au",{"name":108,"role":34,"phone":26,"phoneExt":26,"email":26},"Amanda Gwee",{"facility":110,"status":44,"city":111,"state":112,"zip":113,"country":48,"countryCode":49,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Perth Children's Hospital","Perth","Western Australia","6000",{"type":51,"coordinates":115},[116,117],115.8614,-31.95224,{"lat":117,"lon":116},[120,124],{"name":121,"role":38,"phone":122,"phoneExt":26,"email":123},"Daniel Yeoh, Dr","+614 2352 0575","daniel.yeoh@health.wa.gov.au",{"name":125,"role":34,"phone":26,"phoneExt":26,"email":26},"Daniel Yeoh",{"type":127,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100493736","phase-3-fosfomycin-versus-standard-of-care-in-children-with-antibiotic-resistant-urinary-tract-infections-100493736",false,"NCT05709028","Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections","Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections: A Non-inferiority, Pragmatic, Multi-centre Adaptive Trial to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral Fosfomycin in Children With Antibiotic-resistant Urinary Tract Infections.","FosUTI","Inclusion Criteria:\n\nChildren aged ≥6 months to \\\u003C18 years with:\n\n1. Symptoms consistent with a clinical diagnosis of a UTI (as per the treating clinician); AND\n2. Microbiological confirmation: Defined as a urine culture revealing a predominant growth of a bacterial uropathogen \\[≥10\\^6 CFU\u002FL, or ≥10\\^3 CFU\u002FmL\\] together with ≥10x10\\^6 white blood cells on microscopy; AND\n3. The bacterial uropathogen is a non-pseudomonal gram-negative organism likely to cause urinary tract infections in children; being one of either: Escherichia coli, Proteus spp., Klebsiella spp., Enterobacter spp., Serratia spp., or Citrobacter spp., AND\n4. The uropathogen has in vitro evidence of resistance to all oral penicillins and oral first- and second- generation cephalosporins (or is presumed to be resistant based on the pattern of phenotypic testing); AND\n5. The patient has not yet received \\>48 hours of antibiotics with in vitro activity against the urinary pathogen prior to enrolment.\n\n   Exclusion Criteria:\n6. Evidence of bacteraemia due to the same uropathogen within the same clinical illness; OR\n7. Evidence of infection at a secondary site (such as meningitis or endocarditis); OR\n8. Children with features suggestive of sepsis (defined as requiring inotropic support, or \\>20ml\u002Fkg fluid bolus); OR\n9. Children who are unable to tolerate or absorb oral antibiotics; OR\n10. Children with severe renal unsifficiency (creatinine clearance \\\u003C10ml\u002Fminute\u002F1.73m\\^2); OR\n11. Known allergy to fosfomycin; OR\n12. A decision by the primary treating physician that enrolment in the trial is not in the child's best interest.","ALL","6 Months","17 Years",{"count":140,"type":141},300,"ESTIMATED","INTERVENTIONAL",[144],"PHASE3","Urinary tract infections (UTIs) are among the most common bacterial infections in children. Up to 50% of UTI's are caused by multi-drug resistant ESBL-producing gram negative bacteria that do not respond to treatment with oral penicillin's or cephalosporins. Instead, children often require hospital admission to receive broad-spectrum intravenous antibiotics when they may otherwise be safely managed at home; resulting in prolonged hospital stays and an increased use of health resources. Fosfomycin is a broad-spectrum antibiotic discovered in 1969 that remains susceptible to a large number of organisms due to its low international use. Fosfomycin can be prepared as an oral solution with an orange\u002Ftangerine flavour and is currently approved for use in females \\>12 years old. Despite extensive evidence of its efficacy in adults and safety in neonates, the use of fosfomycin in children remains limited and fosfomycin is not currently licensed for use in children \\\u003C12 years old in Australia.\n\nThe aim of this clinical trial is to compare the use of oral fosfomycin against standard of care antibiotics for the treatment of antibiotic resistant urinary tract infections in children. The main questions the trial aims to answer are:\n\n1. Is oral fosfomycin non-inferior in efficacy to the current standard of care for the treatment of antibiotic-resistant urinary tract infections in children?\n2. Is oral fosfomycin a safe and well-tolerated antibiotic in children?\n3. What is the best dosing regimen of oral fosfomycin for the treatment of antibiotic-resistant UTIs in children?",[147],"Urinary Tract Infections","2024-06-04",{"date":150,"type":151},"2024-06-06","ACTUAL",{"date":153,"type":151},"2023-08-02",{"date":155,"type":141},"2027-08",{"name":5,"class":6},5]