[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481097":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":55,"responsibleParty":257,"collaborators":27,"id":259,"slug":260,"hasResults":261,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":261,"sex":267,"minAge":268,"maxAge":269,"enrollmentInfo":270,"targetDuration":27,"studyType":273,"phases":274,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":76,"whyStopped":27,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group: Discontinuation of treatment","EXPERIMENTAL","For patients randomized in the experimental group, the patient receives 3-day IV therapy and the treatment is interrupted.",[13,14,15],"Drug: IV Antibacterial Agents","Procedure: Fecal\u002FRectal Swab","Procedure: PCT assay",{"label":17,"type":6,"description":18,"interventionNames":19},"Control group: Usual practice","For patients randomized in the control group, the treatment for acute pyelonephritis is based on the attending clinician's practice and according to the usual practice: 3-day IV therapy followed by a 7-day oral antibiotic therapy.",[13,20,14,15],"Drug: Orally antibacterial agents",[22,28,32,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","IV Antibacterial Agents","Ceftriaxone (50 mg\u002Fkg once a day by intravenous\u002Fintramuscular route) AND\u002FOR Amikacin (20 mg\u002Fkg once a day by intravenous\u002Fintramuscular route) during 3 days. .",[17,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Orally antibacterial agents","Cotrimoxazole (sulfamethoxazole\u002Ftrimethoprime) 30mg\u002Fkg\u002Fday (2 divided doses) OR Cefixime 8mg\u002Fkg\u002Fday (2 divided doses) during 7 days",[17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"PROCEDURE","Fecal\u002FRectal Swab","Collected by the nurse or the physician (D0,D3,D10 or 17 and D31 or D38), either by a rectal swab, either by fecal swab (dip of the swab in fresh stools \\\u003C 4 hours, which will occur frequently in our population of children aged 1 month to 3 years, and will in particular be possible for hospitalized children) using a FecalSwabTM, that contains a transport medium.",[17,9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":27},"PCT assay","Dosage of procalcitonin (if not performed in standard care) at D0",[17,9],[42],{"name":43,"affiliation":44,"role":45},"Jean GASCHIGNARD, PhD","Hôpital Paris-Saclay","PRINCIPAL_INVESTIGATOR",[47,51],{"name":43,"role":48,"phone":49,"phoneExt":27,"email":50},"CONTACT","+33 1 69 15 96 00","j.gaschignard@ghne.fr",{"name":52,"role":48,"phone":53,"phoneExt":27,"email":54},"Romain BASMACI, PhD","+33 1 47 60 63 58","romain.basmaci@aphp.fr",[56,74,88,102,116,130,144,157,165,178,192,206,219,233,245],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"CH Sud Francilien","NOT_YET_RECRUITING","Corbeil-Essonnes","Essonne","91100","France","FR",{"type":65,"coordinates":66},"Point",[67,68],2.48757,48.60603,{"lat":68,"lon":67},[71],{"name":72,"role":48,"phone":27,"phoneExt":27,"email":73},"Sébastien Rouget, Dr","sebastien.rouget@chsf.fr",{"facility":75,"status":76,"city":77,"state":60,"zip":78,"country":62,"countryCode":63,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Paris-Saclay hospital","RECRUITING","Orsay","91400",{"type":65,"coordinates":80},[81,82],2.18727,48.69572,{"lat":82,"lon":81},[85],{"name":86,"role":48,"phone":27,"phoneExt":27,"email":87},"Jean Gaschignard, PhD","J.GASCHIGNARD@gh-nord-essonne.fr",{"facility":89,"status":58,"city":90,"state":91,"zip":92,"country":62,"countryCode":63,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Antoine Beclère Hospital","Clamart","Haut de Seine","92140",{"type":65,"coordinates":94},[95,96],2.26692,48.80299,{"lat":96,"lon":95},[99],{"name":100,"role":48,"phone":27,"phoneExt":27,"email":101},"Etienne Bizot, Dr","etienne.bizot@aphp.fr",{"facility":103,"status":76,"city":104,"state":105,"zip":106,"country":62,"countryCode":63,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Ambroise Paré hospital","Boulogne","Hauts de Seine","92100",{"type":65,"coordinates":108},[109,110],-1.3194,46.79346,{"lat":110,"lon":109},[113],{"name":114,"role":48,"phone":27,"phoneExt":27,"email":115},"Bilade Cherqaoui, Dr","bilade.cherqaoui2@aphp.fr",{"facility":117,"status":58,"city":118,"state":119,"zip":120,"country":62,"countryCode":63,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Children-Teenager hospital","Nantes","Loire Atlantique","44000",{"type":65,"coordinates":122},[123,124],-1.55336,47.21725,{"lat":124,"lon":123},[127],{"name":128,"role":48,"phone":27,"phoneExt":27,"email":129},"Justine Franco, Pr","justine.franco@chu-nantes.fr",{"facility":131,"status":58,"city":132,"state":133,"zip":134,"country":62,"countryCode":63,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Jeanne Flandre Hospital","Lille","Nord","59000",{"type":65,"coordinates":136},[137,138],3.05512,50.63391,{"lat":138,"lon":137},[141],{"name":142,"role":48,"phone":27,"phoneExt":27,"email":143},"François Dubos, Pr","francois.dubos@chu-lille.fr",{"facility":145,"status":58,"city":146,"state":146,"zip":147,"country":62,"countryCode":63,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Robert Debré Hospital","Paris","75019",{"type":65,"coordinates":149},[150,151],2.3488,48.85341,{"lat":151,"lon":150},[154],{"name":155,"role":48,"phone":27,"phoneExt":27,"email":156},"Jeanne Truong, Dr","jeanne.truong@aphp.fr",{"facility":145,"status":58,"city":146,"state":146,"zip":147,"country":62,"countryCode":63,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},{"type":65,"coordinates":159},[150,151],{"lat":151,"lon":150},[162],{"name":163,"role":48,"phone":27,"phoneExt":27,"email":164},"Claire Ferrua, Dr","Claire.ferrua@aphp.fr",{"facility":166,"status":58,"city":167,"state":168,"zip":169,"country":62,"countryCode":63,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Meaux Hospital","Meaux","Seine et Marne","77100",{"type":65,"coordinates":171},[172,173],2.87885,48.96014,{"lat":173,"lon":172},[176],{"name":177,"role":48,"phone":27,"phoneExt":27,"email":27},"Olivier Vignaud, Dr",{"facility":179,"status":58,"city":180,"state":181,"zip":182,"country":62,"countryCode":63,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Jean Verdier Hospital","Bondy","Seine St Denis","93140",{"type":65,"coordinates":184},[185,186],2.48931,48.9018,{"lat":186,"lon":185},[189],{"name":190,"role":48,"phone":27,"phoneExt":27,"email":191},"Aurelien Galerne, Dr","aurelien.galerne@aphp.fr",{"facility":193,"status":58,"city":194,"state":195,"zip":196,"country":62,"countryCode":63,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Intercomunal Créteil Hospital","Créteil","Val de Marne","94000",{"type":65,"coordinates":198},[199,200],2.46569,48.79266,{"lat":200,"lon":199},[203],{"name":204,"role":48,"phone":27,"phoneExt":27,"email":205},"Juliette Daire, Dr","Juliette.Daire@chicreteil.fr",{"facility":207,"status":58,"city":208,"state":195,"zip":209,"country":62,"countryCode":63,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Kremlin Bicêtre Hospital","Le Kremlin-Bicêtre","94270",{"type":65,"coordinates":211},[212,213],2.36073,48.81471,{"lat":213,"lon":212},[216],{"name":217,"role":48,"phone":27,"phoneExt":27,"email":218},"Cécile Thivent, Dr","cecile.thivent@aphp.fr",{"facility":220,"status":76,"city":221,"state":222,"zip":223,"country":62,"countryCode":63,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Andre mignot hospital","Le Chesnay","Yvelines","78150",{"type":65,"coordinates":225},[226,227],2.12213,48.8222,{"lat":227,"lon":226},[230],{"name":231,"role":48,"phone":27,"phoneExt":27,"email":232},"Sylvie Nathanson, Dr","snathanson@ch-versailles.fr",{"facility":234,"status":58,"city":235,"state":27,"zip":27,"country":62,"countryCode":63,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"GHEF Site Marne la vallée","Jossigny",{"type":65,"coordinates":237},[238,239],2.75432,48.83765,{"lat":239,"lon":238},[242],{"name":243,"role":48,"phone":27,"phoneExt":27,"email":244},"Nathalie Garrec, Dr","ngarrec@ghef.fr",{"facility":246,"status":58,"city":247,"state":27,"zip":27,"country":62,"countryCode":63,"cosmosGeoPoint":248,"geoPoint":252,"contacts":253},"CHU Toulouse","Toulouse",{"type":65,"coordinates":249},[250,251],1.44367,43.60426,{"lat":251,"lon":250},[254],{"name":255,"role":48,"phone":27,"phoneExt":27,"email":256},"Benjamin Hallak, Dr","hallak.b@chu-toulouse.fr",{"type":258,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100481097","phase-4-3-day-iv-antibiotic-treatment-versus-3-day-iv-followed-by-7-day-oral-antibiotic-treatment-for-ap-in-children-100481097",false,"NCT05544565","3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children","3-day Intravenous Antibiotic Treatment Versus 3-day Intravenous Followed by 7-day Oral Antibiotic Treatment for Acute Pyelonephritis in Children 1 Month to 3 Years Old: a Non-inferiority Open Randomized Multicentric Clinical Trial","PYELOCOURT","Inclusion Criteria:\n\n* Age ≥ 1 month and \\\u003C 3 years\n* For children younger than 3 months, gestational age \\> 34 WA\n* First episode of urinary tract infection\n* AP defined by temperature ≥ 38°C on day of diagnosis AND positive urinalysis (white cell counts ≥ 10\\^4\u002FmL) with a positive urine culture with one Gram- negative bacillus ≥ 104 UFC\u002FmL. The child temperature will have to be measured with a thermometer according to the French national recommendations \\[Health Insurance website (AMELI ;see: - https:\u002F\u002Fwww.ameli. fr\u002Fassure\u002Fsante\u002Fbons-gestes\u002Fsoins\u002Fprendre-temperature); HAS (see: https:\u002F\u002Fwww.has-sante. fr\u002Fjcms\u002Fc\\_2674284\u002Ffr\u002Fprise-en-charge-de-la-fievre-chez-l-enfant)\\].\n* Initial treatment by either ceftriaxone AND\u002FOR amikacin\n* Outpatient or hospitalised\n\nNon-inclusion Criteria:\n\n* Urine collected by bag\n* Urine culture growing more than one dominant bacterium (cf section 6.2 of the protocol)\n* Catheter-associated acute pyelonephritis\n* Known congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \\\u003C 10 mm)\n* Previous surgery of the genitourinary tract (except circumcision in male children)\n* Abnormal renal function for age and weight (defined by a serum creatinine \\>40µmol\u002FL before 1 year and \\>75µmol between 1 year et 3 years)\n* Known immunocompromising condition (e.g., HIV, primary immunodeficiency, sickle cell disease, use of chronic corticosteroids or other immunosuppressive agents)\n* Antibiotic prophylaxis for any reason OR antibiotic treatment in the last 7 days (except treatment administered for the AP)\n* Known hypersensitivity to at least one of the active substances \u002Fexcipients: ceftriaxone (including other cephalosporins and other beta-lactams) and amikacin (including other aminoglycosids).\n* Known hypersensitivity to at least one of the active substances \u002Fexcipients: cotrimoxazole (=sulfamethoxazole\u002Ftrimethoprim) (including other drugs containing sulfonamides) and cefixime (including other cephalosporins)\n* Known blood dyscrasias (megaloblastic haematopoiesis)\n* Known severe hepatic insufficiency\n* Known G6PD deficiency\n* No written consent from holders of parental authority\n* Non-affiliation to a social security system (as beneficiary or entitled person)\n* Children whose follow-up is not carried out in the centre\n* Participation in another interventional or minimal risk trial\n\nRandomization criteria :\n\n* Three days of taking antibiotics (IV or IM) (no interruption or discontinuation)\n* Positive urine culture with Gram negative bacillus ≥ 10\\^4 UFC\u002FmL\n* Favorable clinical outcome at day of randomization (D2 or D3) defined by temperature \\\u003C 38°C at day of randomization and absence of fever measured \\> 38°C for at least 12 hours AND no abdominal pain AND no feeding problem AND investigator agreement\n* No renal abscess AND congenital anomalies of the kidney and genitourinary tract (other than vesicoureteral reflux and pyelocaliceal dilatation \\\u003C 10 mm) on the renal ultrasound performed between D0 and day of randomization\n* No more than 1 type of dominant bacteria on the urine culture\n* Sensitivity to the initial antibiotic treatment\n* Sensitivity to cefixime OR cotrimoxazole","ALL","1 Month","3 Years",{"count":271,"type":272},480,"ESTIMATED","INTERVENTIONAL",[275],"PHASE4","Antibiotic therapies currently recommended for the treatment of acute pyelonephritis (AP) in children, whether fully by the oral route or initially intravenous (IV, 3 days) followed by the oral route, have a duration of 7 to 14 days (10 days in France).\n\nIn children with no prior urological malformation, the global clinical and microbiological cure rate after antibiotic treatment completion is around 95%. Recurrence occurs in less than 5% of cases in the 3 months following AP. Renal scarring, when documented, concerns 15% of children 6 months after treatment. Renal scarring can be associated with chronic renal disease.\n\nThe investigators hypothesize that 3 days of IV treatment is equivalent to extending to 10 days with an oral to treat AP in children.\n\nThe investigators also hypothesize that while achieving equivalent clinical and prevention of re-infections in the following 3 months, 3 days of IV treatment reduces the risk of acquisition of resistant strains of Enterobacteriaceae and increases the gut microbotia diversity compared to extending to 10 days with an oral therapy.",[278],"Pyelonephritis Acute",[280,281,282,283],"Pyelonephritis acute","Antibiotic therapies","Renal scar","Paediatric","2026-01-05",{"date":286,"type":287},"2026-01-07","ACTUAL",{"date":289,"type":287},"2023-03-22",{"date":291,"type":272},"2028-01",{"name":5,"class":6},15]