[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502205":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":27,"locations":35,"responsibleParty":96,"collaborators":99,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":10,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":10,"studyType":115,"phases":10,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral antibiotic therapy",null,"Clinically stable (see eligibility criteria) children without any past high-risk medical history (see eligibility criteria) will initiate oral antibiotic therapy.",[13],"Drug: Oral antibiotic therapy",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","Empirical choice: amoxicillin-clavulanic acid 50 mg\u002Fkg\u002Fday divided into three doses.\n\nIf the sensitivity pattern is available, another oral antibiotic, preferably smaller-spectrum, can be used instead.\n\nTotal duration of antibiotic therapy will be 10 days.",[9],[20,24],{"name":21,"affiliation":22,"role":23},"Naqash Sethi, MD","Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":22,"role":26},"Ulrikka Nygaard, Ass. prof, Ph.D.","STUDY_CHAIR",[28,32],{"name":21,"role":29,"phone":30,"phoneExt":10,"email":31},"CONTACT","+4528405083","naqash.javaid.sethi.02@regionh.dk",{"name":25,"role":29,"phone":33,"phoneExt":10,"email":34},"+4535459761","ulrikka.nygaard@regionh.dk",[36,54,68,82],{"facility":37,"status":38,"city":39,"state":10,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Copenhagen University Hospital Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":44,"coordinates":45},"Point",[46,47],12.56553,55.67594,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":10,"email":53},"Line Sehested, MD","35455220","line.thousig.sehested.01@regionh.dk",{"facility":55,"status":38,"city":56,"state":10,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Copenhagen University Hospital Herlev","Herlev","2730",{"type":44,"coordinates":59},[60,61],12.43998,55.72366,{"lat":61,"lon":60},[64],{"name":65,"role":29,"phone":66,"phoneExt":10,"email":67},"Mette Christensen, MD","+4538685379","mette.marie.christensen@regionh.dk",{"facility":69,"status":38,"city":70,"state":10,"zip":71,"country":41,"countryCode":42,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Copenhagen University Hospital Hillerød","Hillerød","3400",{"type":44,"coordinates":73},[74,75],12.30081,55.92791,{"lat":75,"lon":74},[78],{"name":79,"role":29,"phone":80,"phoneExt":10,"email":81},"Claudia Kai, Ph.D.","+4548296836","claudia.mau.kai.03@regionh.dk",{"facility":83,"status":38,"city":84,"state":10,"zip":85,"country":41,"countryCode":42,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Copenhagen University Hospital Hvidovre","Hvidovre","2650",{"type":44,"coordinates":87},[88,89],12.47708,55.64297,{"lat":89,"lon":88},[92],{"name":93,"role":29,"phone":94,"phoneExt":10,"email":95},"Dina Cortes, Prof., DSMc","+4538626602","dina.cortes@regionh.dk",{"type":23,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ulrikka Nygaard","Principal investigator",[100],{"name":101,"class":6},"Hvidovre University Hospital","100502205","oral-antibiotics-alone-in-children-aged-4-weeks-to-2-months-with-a-urinary-tract-infection-100502205",false,"NCT05819229","Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection","Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Suspected or Confirmed Uncomplicated Urinary Tract Infection. A Single-arm Multicenter Prospective Observational Study.","INCLUSION CRITERIA:\n\n1. Clinical suspicion of urinary tract infection irrespective of the presence of fever.\n2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal).\n3. 4 weeks to 2 months of age (corrected age, if premature).\n\nAll children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists.\n\nA positive urine culture is defined as:\n\n* Suprapubic bladder aspiration: any growth of bacteria.\n* Sterile intermittent catheterization: monoculture with ≥10\\^3 colony forming units per milliliter (cfu\u002Fml).\n* Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\\^4 cfu\u002Fml.\n* Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\\^5 cfu\u002Fml in one test and 10\\^3 cfu\u002Fml in another test.\n\nEXCLUSION CRITERIA:\n\n1. Non-Danish civil registration number.\n2. High-risk medical history.\n\n   1. Previous urinary tract infection.\n   2. Prophylactic antibiotic treatment.\n   3. Known urogenital abnormality (i.e., hydronephrosis (pyelectasis ≥10 mm or\u002Fand caliectasis ≥5 mm); hydroureter; vesicoureteral reflux; multicystic dysplasia; renal dysplasia; renal hypoplasia; renal agenesis; duplex kidney; ectopic placed kidneys; polycystic kidney disease; neurogenic bladder dysfunction; and hypospadias).\n   4. Previous hospitalization needing antibiotic therapy.\n3. Markedly elevated c-reactive protein indicating bacteremia.\n4. Elevated creatinine.\n5. Oral therapy is not possible (e.g., frequent vomiting or excessive regurgitation).","ALL","4 Weeks","2 Months",{"count":113,"type":114},125,"ESTIMATED","OBSERVATIONAL","The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.",[118],"Urinary Tract Infections in Children",[120,121,122],"Antibiotic therapy","Urinary tract infection","Children","2024-07-05",{"date":125,"type":126},"2024-07-08","ACTUAL",{"date":128,"type":126},"2023-02-27",{"date":130,"type":114},"2025-05-01",{"name":5,"class":6},4]