[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502205":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":27,"locations":35,"responsibleParty":95,"collaborators":98,"id":101,"slug":10,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":10,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":10,"studyType":113,"phases":10,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"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",[36,53,67,81],{"facility":37,"status":38,"city":39,"state":10,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Copenhagen University Hospital Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark",{"type":43,"coordinates":44},"Point",[45,46],12.56553,55.67594,{"lat":46,"lon":45},[49],{"name":50,"role":29,"phone":51,"phoneExt":10,"email":52},"Line Sehested, MD","35455220","line.thousig.sehested.01@regionh.dk",{"facility":54,"status":38,"city":55,"state":10,"zip":56,"country":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Copenhagen University Hospital Herlev","Herlev","2730",{"type":43,"coordinates":58},[59,60],12.43998,55.72366,{"lat":60,"lon":59},[63],{"name":64,"role":29,"phone":65,"phoneExt":10,"email":66},"Mette Christensen, MD","+4538685379","mette.marie.christensen@regionh.dk",{"facility":68,"status":38,"city":69,"state":10,"zip":70,"country":41,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Copenhagen University Hospital Hillerød","Hillerød","3400",{"type":43,"coordinates":72},[73,74],12.30081,55.92791,{"lat":74,"lon":73},[77],{"name":78,"role":29,"phone":79,"phoneExt":10,"email":80},"Claudia Kai, Ph.D.","+4548296836","claudia.mau.kai.03@regionh.dk",{"facility":82,"status":38,"city":83,"state":10,"zip":84,"country":41,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Copenhagen University Hospital Hvidovre","Hvidovre","2650",{"type":43,"coordinates":86},[87,88],12.47708,55.64297,{"lat":88,"lon":87},[91],{"name":92,"role":29,"phone":93,"phoneExt":10,"email":94},"Dina Cortes, Prof., DSMc","+4538626602","dina.cortes@regionh.dk",{"type":23,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ulrikka Nygaard","Principal investigator",[99],{"name":100,"class":6},"Hvidovre University Hospital","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":111,"type":112},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.",[116],"Urinary Tract Infections in Children",[118,119,120],"Antibiotic therapy","Urinary tract infection","Children","2024-07-05",{"date":123,"type":124},"2024-07-08","ACTUAL",{"date":126,"type":124},"2023-02-27",{"date":128,"type":112},"2025-05-01",{"name":5,"class":6},4]