[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pyelonephritis-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pyelonephritis-acute":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":21,"type":22},480,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Pyelonephritis Acute",[30,31,32,33],"Pyelonephritis acute","Antibiotic therapies","Renal scar","Paediatric","RECRUITING","2026-01-05",{"date":37,"type":38},"2026-01-07","ACTUAL",{"date":40,"type":38},"2023-03-22",{"date":42,"type":22},"2028-01",{"name":44,"class":45},"Assistance Publique - Hôpitaux de Paris","OTHER",15,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100485166","phase-3-efficacy-of-7-days-versus-14-days-of-antibiotic-therapy-for-acute-pyelonephritis-in-kidney-transplant-recipients-a-multicentre-randomized-non-inferiority-trial-100485166","NCT05597540","Efficacy of 7 Days Versus 14 Days of Antibiotic Therapy for Acute Pyelonephritis in Kidney Transplant Recipients, a Multicentre Randomized Non-inferiority Trial.","SHORTCUT","Inclusion Criteria:\n\n* Age \\>18 years KTR\n* APN defined by: fever (T°≥38°C) (with or without clinical signs and\u002For symptoms of UTI) and pyuria (≥10\\^4 white blood cells\u002FmL or ≥10\u002Fmm3) and positive urine culture (uropathogen ≥10\\^3 CFU\u002FmL susceptible to the empirically administrated antibiotic)\n* No confirmed or suspected febrile non urinary bacterial infection\n* No urologic\u002Frenal complication at baseline imaging (abscess, obstruction...)\n* Favourable early response to antibiotic treatment:48 to 60 hours after the first dose of antibiotic effective against the causative uropathogen) defined by: T°\\\u003C38°C and improvement (or resolution) of signs and\u002For symptoms of urinary tract infection if present at diagnosis\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe or complicated condition\n\n  * Any rapidly progressing disease or immediately life-threatening illness, including, but not limited to, septic shock, current or impeding respiratory failure, acute heart or liver failure\n  * Admission or stay in intensive care unit at baseline\n  * Obstruction of the urinary tract\n  * Renal, perinephric or prostatic abscess\n* Prior inclusion in this study\n* Current participation to another interventional study\n* Dual antibiotic therapy (prophylactic antibiotic such as cotrimoxazole allowed) (only 1 dose of aminoside is allowed before randomization)\n* First month post transplantation\n* Current indwelling catheter (including bladder catheter, ureteral stents, percutaneous nephrostomy tubes)\n* Neurogenic bladder\n* Enterocystoplasty\n* Immunodeficiency or immunosuppressive therapy not related to kidney transplantation including hematologic malignancy, cancer, asplenia, neutropenia\\\u003C500 neutrophils\u002Fmm3\n* Pregnancy, breastfeeding\n* Hypersensitivity or previous severe adverse drug reaction to the antibiotic therapy\n* Unable or unwilling, in the judgment of the investigator, to comply with the protocol\n* Life expectancy\\\u003C1 month\n* Patient under legal guardianship or without healthcare coverage\n* Homeless patient\n* Women with childbearing potential not using adequate contraception","18 Years",{"count":56,"type":22},470,[58],"PHASE3","Infections are a major cause of morbidity and mortality in solid organ transplant recipients. In kidney transplant recipients (KTR) urinary tract infection (UTI) represent 45-72% of all infections, and 30% of all hospitalizations for sepsis. Acute transplant pyelonephritis are the most common complications occurring in more than 20% of patients, mainly in the first year after transplantation. They are associated with an increased risk of acute kidney rejection and long-term kidney graft dysfunction. Gram-negative bacteria, mainly E. coli, account for more than 70% of UTI in KTR. As those infections are favoured by urinary tract modifications\u002Fdefects and immunosuppression, they are often recurrent and necessitate repeated courses of antibiotics. Selective pressure due to antibiotic consumption, along with frequent hospital admissions and immunosuppression, are well known risk factors for the development of antibiotic resistant infections. Multidrug (MDR)- or extensively (XDR)- drug resistant Enterobacteriaceae including ESBL- or carbapenemase-producing organisms, are thus increasingly observed in transplant units and represent a global threat as very few new antibiotics are expected in the next decade.\n\nOne main strategy to limit antimicrobial resistance is to reduce the duration of antibiotic treatment. A 7 day-course is recommended for simple acute pyelonephritis (APN) treated with fluoroquinolones or parenteral B-lactams, prolonged up to 10 or 14 days in the presence of underlying disease at risk of complications. Most KT teams treat patients between 14-21 days as recommended by American guidelines. However, the need to extend treatment duration in immunosuppressed patients is a poorly defined concept and the optimal duration of treatment for APN in KTR is not known as these patients are excluded from most studies.\n\nAs there is an urgent need to reduce antibiotic consumption in this population at high risk of developing infections due to resistant pathogens, the hypothesis is that a 7 day-treatment is sufficient to cure APN with good clinical response after 48h of treatment in KTR and is as effective as 14 days.",[28,61],"Kidney Transplant Infection",[63,64],"antibiotic therapy","duration of antibiotic treatment reduction","2024-05-26",{"date":67,"type":38},"2024-05-29",{"date":69,"type":38},"2024-02-22",{"date":71,"type":22},"2027-08-22",{"name":44,"class":45},9,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100359368","the-validity-of-the-quick-renal-mri-in-pediatric-kidney-disease-100359368","NCT03959163","The Validity of the Quick Renal MRI in Pediatric Kidney Disease","Inclusion Criteria:\n\n* Aim 1:\n\n  * Patient is admitted to American Family Children's Hospital for a febrile UTI, suspected pyelonephritis, or diagnosed pyelonephritis\n  * Undergoing clinical DMSA scan\n* Aim 2:\n\n  * Undergoing DMSA scans as a part of their routine clinical care\n  * History of more than one UTI in the past year\n\nExclusion Criteria:\n\n* Aim 1:\n\n  * No evidence of pyuria on their urine analysis\n  * Negative urine culture\n  * Not comfortable with having a Quick MRI performed\n* Both aims:\n\n  * Contraindications to MRI","0 Years","21 Years",{"count":83,"type":22},100,[85],"NA","The investigators propose a new imaging method for children born with congenital anomalies of the urinary tract that is a rapid, injection-, sedation-, and radiation-free alternative: the quick renal MRI. This proposal hypothesizes that the quick renal MRI has high validity compared to current radiologic standard for renal infection and scarring, the 99mTechnetium-dimercaptosuccinic acid (99mTc- DMSA) renal scan in the detection of acute renal infections and scars. If the quick renal MRI is accurate, it could potentially replace the DMSA scan for those specific questions and ease the burden of testing for children with chronic renal disease. Findings from these studies will provide preliminary data and rationale for a multi-centered study to further test this new technology.\n\nParticipants will be 0-21 years of age and can expect to be on study for from 1 week (if enrolled in Aim 1) to 6 months (if enrolled in Aim 2).",[88,28,89],"Pyelonephritis","Renal Sclerosis","2024-04-02",{"date":92,"type":38},"2024-04-03",{"date":94,"type":38},"2019-05-07",{"date":96,"type":22},"2025-01",{"name":98,"class":45},"University of Wisconsin, Madison",1]