[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456500":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":42,"locations":52,"responsibleParty":112,"collaborators":11,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":11,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":11,"overallStatus":55,"whyStopped":11,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Lund University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PAC treatment","EXPERIMENTAL",null,[13],"Drug: Pivmecillinam and amoxicillin\u002Fclavulanic acid",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard treatment","ACTIVE_COMPARATOR",[18],"Drug: Standard treatment, ciprofloxacin, trimethoprim\u002Fsulfamethoxazole or ertapenem depending on susceptibility",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Pivmecillinam and amoxicillin\u002Fclavulanic acid","1 tablet pivmecillinam 400 mg and 1 tablet Amoxicillin\u002Fclavulanic acid 875\u002F125 mg, three times daily.",[9],[26],"Coactin or selexid etc, and Augmentin or Clavulin etc",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Standard treatment, ciprofloxacin, trimethoprim\u002Fsulfamethoxazole or ertapenem depending on susceptibility","Ciprofloxacin 500 mg twice daily, trimethoprim\u002Fsulfamethoxazole 800 mg\u002F160 mg twice daily or ertapenem 1 g once daily.",[15],[32],"Bactrim",[34,38],{"name":35,"affiliation":36,"role":37},"Oskar Ljungquist, MD, PhD.","Lunds universitet","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":41},"Emeli Månsson, MD, PhD.","Västmanland Hospital Västeras","STUDY_CHAIR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Oskar Ljungquist, M.D, PhD","CONTACT","+46424063182","oskar.ljungquist@med.lu.se",{"name":49,"role":45,"phone":50,"phoneExt":11,"email":51},"Jonas Tverring, M.D, PhD","+46424062673","jonas.tverring@med.lu.se",[53,68,79,90,101],{"facility":54,"status":55,"city":56,"state":11,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Helsingborg hospital","RECRUITING","Helsingborg","Sweden","SE",{"type":60,"coordinates":61},"Point",[62,63],12.69437,56.04673,{"lat":63,"lon":62},[66],{"name":67,"role":45,"phone":11,"phoneExt":11,"email":11},"Oskar Ljungquist, PhD",{"facility":69,"status":55,"city":70,"state":11,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Kristianstad hospital","Kristianstad",{"type":60,"coordinates":72},[73,74],14.15242,56.03129,{"lat":74,"lon":73},[77],{"name":78,"role":45,"phone":11,"phoneExt":11,"email":11},"Emil Thiman",{"facility":80,"status":55,"city":81,"state":11,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Skåne University Hospital, Lund","Lund",{"type":60,"coordinates":83},[84,85],13.19321,55.70584,{"lat":85,"lon":84},[88],{"name":89,"role":45,"phone":11,"phoneExt":11,"email":11},"Christian Kampmann, PhD",{"facility":91,"status":55,"city":92,"state":11,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Skåne University Hospital, Malmö","Malmö",{"type":60,"coordinates":94},[95,96],13.00073,55.60587,{"lat":96,"lon":95},[99],{"name":100,"role":45,"phone":11,"phoneExt":11,"email":11},"Johan Tham, Ass professor",{"facility":102,"status":55,"city":103,"state":11,"zip":11,"country":57,"countryCode":58,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Västmanland hospital Västerås","Västerås",{"type":60,"coordinates":105},[106,107],16.55276,59.61617,{"lat":107,"lon":106},[110],{"name":111,"role":45,"phone":11,"phoneExt":11,"email":11},"Emeli Månsson, PhD",{"type":113,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100456500","phase-3-pivmecillinam-with-amoxicillinclavulanic-acid-for-step-down-oral-therapy-in-esbl-utis-100456500",false,"NCT05224401","Pivmecillinam With Amoxicillin\u002FClavulanic Acid for Step Down Oral Therapy in ESBL UTIs","Pivmecillinam With Amoxicillin\u002FClavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI)","PACUTI","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Fever (≥ 38.3 C) or shaking chills at least once at home or in hospital\n3. Clinical suspicion of UTI including at least one of the following symptoms:\n\n   1. Dysuria, urinary urgency, difficulty urinating, new or worsened urinary incontinence, macroscopic haematuria or increased urinary frequency\n   2. Low abdominal pain or flank pain with percussion or palpation tenderness over kidneys and\u002For bladder.\n4. Urine (≥ 103 CFU\u002FmL) and\u002For blood culture positive for EPE\\* with susceptibility to pivmecillinam†.\n5. In-patient who has received 1-5 days of EPE-active‡ intravenous antibiotics\n6. Discontinuing parenteral treatment and starting treatment with oral antibiotics is considered safe according to the treating physician.\n\n   * EPE refers to ESBL-producing Enterobacterales. This includes Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Klebsiella oxytoca, and Citrobacter koseri.\n\n     * Susceptibility for pivmecillinam in the study is based on zone diameter breakpoints for pyelonephritis (≥ 20 mm) which was received by personal communication with professor Christian Giske, the chairman of the European Committee of Antimicrobial Susceptibility Testing (EUCAST) (26).\n\n       * EPE-active intravenous antibiotics refers to EUCAST susceptibility testing and will most often be piperacillin-tazobactam, meropenem or imipenem-cilastatin in the Swedish setting, and less often aminoglycosides or newer beta-lactamase-inhibitor-containing beta-lactam antibiotics (27). Participants who have only received one dose of EPE-active intravenous antibiotics are also eligible and are considered within the \"1-5 days\" of antibiotics.\n\nPatients may only be recruited and randomised once in this trial.\n\nExclusion criteria (any of the following)\n\n1. Known or suspected pregnancy.\n2. Known or suspected life-threatening allergy towards beta-lactam antibiotics.\n3. Clinical isolate of EPE is resistant to ciprofloxacin, TMX and ertapenem.\n4. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \\\u003C10mL\u002Fmin or requiring any form of dialysis.\n5. Severe decompensated liver failure (i.e., child Pugh class B or C).\n6. Genetic metabolic diseases associated with severe carnitine deficiency.\n7. Megaloblastic haematopoiesis.\n8. Co-treatment with valproate or valproic acid (due to interaction with pivmecillinam and ertapenem respectively)\n9. Other reason to which patient is unfit to be included in the study according to treating physician, e.g., cognitive impairment preventing informed consent and follow-up, inability to speak and\u002For read Swedish, missing national personal identification number or missing telephone number preventing follow-up or planned duration of antibiotics \\> 10 days due to complicating factors.","ALL","18 Years","130 Years",{"count":126,"type":127},330,"ESTIMATED","INTERVENTIONAL",[130],"PHASE3","To evaluate if the combination of pivmecillinam and clavulanic acid (PAC) is non-inferior to ciprofloxacin, trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase (ESBL) producing Enterobacterales (EPE).",[133,134,135],"Urinary Tract Infections","Bacteremia","Antibiotic Resistant Infection","2023-08-25",{"date":138,"type":139},"2023-08-28","ACTUAL",{"date":141,"type":139},"2023-05-29",{"date":143,"type":127},"2027-09-01",{"name":5,"class":6},5]