[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complicated-urinary-tract-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complicated-urinary-tract-infection":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100502802","phase-2-a-study-to-investigate-pk-safety-tolerability-of-cefepime-enmetazobactam-in-pediatric-participants-with-cuti-100502802",false,"NCT05826990","A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI","Single Group Phase 2 Study to Investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam Administered by IV Over 2 Hr in Male or Female Participants From Birth to Less Than 18 Years of Age Hospitalised With cUTI","Inclusion Criteria:\n\n* Participant must be from birth to \\\u003C18 years of age. Participants up to 2 months must have been born at term or preterm with a gestational age ≥32 weeks.\n* Written informed consent from parent(s) or other legally acceptable representative(s), and informed assent from participant (if age appropriate according to local regulations).\n* If female and has reached menarche, or has reached Tanner stage 3 development, (even if not having reached menarche) the participant is authorized to participate in this clinical study if the following criteria are met:\n\n  1. Participant has a negative urine and\u002For serum human chorionic gonadotropin test at screening visit. As serum tests may miss an early pregnancy, relevant menstrual history, and sexual history, including methods of contraception, should be considered\n  2. Participant agrees to avoid conception from the time of screening until 7 days after receipt of study intervention and agrees not to attempt pregnancy from the time of screening until 7 days after EOT with study intervention, and participant agrees to follow guidelines received regarding continuation of abstinence, initiation of abstinence or about allowed contraception, and\n  3. Participant reports sexual abstinence for the prior 3 months or reported the use of at least 1 of the acceptable methods of contraception, including an intrauterine device (with copper banded coil), levonorgestrel intrauterine system or regular medroxyprogesterone injections, or participant agrees to initiate sexual abstinence from the time of screening until 7 days after end of treatment (EOT) with study intervention.\n* Participant has a clinically suspected and\u002For bacteriologically documented complicated urinary tract infection (cUTI) or acute pyelonephritis judged by the investigator to require the participant to be hospitalized for treatment with intravenous (i.v.) therapy.\n* The causative pathogen is confirmed or suspected to be susceptible to cefepime-enmetazobactam.\n* Participant has pyuria, defined as dipstick analysis positive for leukocyte esterase OR:\n\n  1. If ≥1 year of age: White blood cell (WBC) count \\>10 cells\u002FµL in unspun urine or ≥10 cells\u002Fhigh power field in spun urine.\n  2. If \\\u003C1 year of age: WBC count \\>5 cells\u002FµL in unspun urine or ≥5 cells\u002Fhigh power field in spun urine.\n* Participant demonstrates clinical signs and\u002For symptoms of either acute pyelonephritis or cUTI at the Screening Visit, as defined by the following criteria:\n\n  a. For pyelonephritis, participants must have at least 2 of the following new or worsening signs and\u002For symptoms: i. If 0 to \\\u003C2 years of age:\n  * Fever (as defined by the investigator)\n  * Failure to thrive\n  * Recent weight loss\n  * Irritability\n  * Poor feeding\n  * Lack of normal level of activity\n  * Abdominal tenderness on physical examination\n  * Vomiting ii. If 2 to \\\u003C18 years of age:\n  * Fever (as defined by the investigator)\n  * Dysuria\n  * Urinary urgency\n  * Urinary frequency\n  * New-onset urinary incontinence\n  * Suprapubic pain, flank pain, or abdominal pain\n  * Suprapubic tenderness or CVA tenderness on physical examination\n  * Nausea or vomiting OR\n\n    b. For cUTI, participants must have at least 2 of the new or worsening signs and\u002For symptoms listed above AND must have at least 1 of the following complicating factors:\n  * Obstructive uropathy\n  * Congenital, functional, or anatomic abnormality of the urogenital tract\n  * Temporary indwelling urinary catheter\n  * Bladder instrumentation within \\\u003C24 hours\n  * Recurrent UTI (≥2 events within a 12-month period)\n* Have a baseline urine culture specimen obtained within 48 hrs prior to the first dose of the study intervention. (Participants may be enrolled in this study and start i.v. study intervention therapy before the Investigator knows the results of the baseline urine culture in the event the causative pathogen is suspected to be susceptible to cefepime-enmetazobactam).\n\nSpecimen is to be obtained by suprapubic aspiration, clean intermittent urethral catheterization, indwelling urethral catheter, or mid- stream clean catch.\n\n* Likely to survive the current illness or hospitalization.\n* Sufficient intravascular access (peripheral or central) to receive study intervention\n\nExclusion Criteria:\n\n* History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to cefepime, any cephalosporin, penicillins, β-lactamase inhibitors (e.g., tazobactam, sulbactam, or clavulanic acid), or other β-lactam agents.\n* Previous enrolment in this study, or in another interventional study ≤30 days before i.v. administration of study intervention.\n* Concurrent infection requiring systemic antibiotics in addition to the i.v. study intervention therapy at the time of first study intervention administration.\n* Receipt of systemic antibiotics within 24 hours before obtaining the study qualifying pre-treatment baseline urine sample and before study intervention therapy. Exceptions are:\n* Receipt up to 24 hours of short-acting antibacterial agent with a daily dose not completed. (Refer protocol ► Section 10.5, Appendix 5 for the list of allowed and disallowed antibiotics).\n\n  * Patients who received prior antimicrobial therapy for the current cUTI\u002FAP, and 1) in the Investigator's opinion, failed that prior antibiotic therapy (i.e., presented with worsening signs and symptoms), AND 2) were documented that the pathogen is non-susceptible to the prior antibiotic therapy.\n  * Patients who have received antimicrobial prophylaxis for recurrent cUTI and then presented signs and symptoms consistent with an active new cUTI or AP.\n* A permanent indwelling bladder catheter or instrumentation including nephrostomy or current urinary catheter or anticipation of urinary catheter placement that would not be removed during the course of i.v. study intervention therapy administration.\n* Participant has suspected or known complete obstruction of any portion of the urinary tract, perinephric abscess, or ileal loops.\n* Participant has trauma to the pelvis or urinary tract.\n* Participant has undergone renal transplantation.\n* Participant has a condition or history of any illness that, in the opinion of the investigator, would have made the participant unsuitable for the study (e.g., may have confounded the results of the study or posed additional risk in administering the study therapy to the participant).\n* Participant is considered unlikely to survive the 6-week study period or had a rapidly progressive illness, including septic shock, that was associated with a high risk of mortality.\n* At the time of first study intervention administration, known presence of a cUTI caused by pathogens resistant to Cefepime - enmetazobactam.\n* Presence of any of the following clinically significant laboratory abnormalities:\n\n  1. Haematocrit \\\u003C25% or haemoglobin \\\u003C8 g\u002FdL (\\\u003C80 g\u002FL, \\\u003C4.9 mmol\u002FL) for children ≥ 1 month, or \\\u003C13 g\u002FdL (\\\u003C130 g\u002FL, \\\u003C8.0 mmol\u002FL) for children \\\u003C 1 month.\n  2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\>3 times the age-specific upper limit of normal (ULN), or total bilirubin \\>2 times ULN (except known Gilbert's disease) and Absolute Neutrophil count\\\u003C1000\u002F mm3.\n  3. eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2. (updated creatinine-based \"Bedside Schwartz\" equation (Schwartz et al. 2009))\n* Participant has baseline QTcB (corrected Bazett's formula) of greater than 450 msec.\n* History of seizures, excluding well-documented febrile seizures of childhood.\n* If female, currently pregnant or breast feeding.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase 2 study is part of regulatory commitments in the United States (PSP) and Europe (PIP) to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI.",[26],"Complicated Urinary Tract Infection","RECRUITING","2026-08-18",{"date":30,"type":31},"2026-08-20","ACTUAL",{"date":33,"type":31},"2023-09-11",{"date":35,"type":20},"2029-05-21",{"name":37,"class":38},"Orchid Pharma Europe GmbH","INDUSTRY",8,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":17,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100429750","phase-4-single-dose-intravenous-antibiotics-for-complicated-urinary-tract-infections-in-children-100429750","NCT04876131","Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children","CHOICE UTI - Clinical Efficacy of Single Dose (Daily) IV Antibiotics Followed by 2 Days Oral Antibiotics Compared to 3 Doses (Daily) IV Antibiotics for Children With Complicated Urinary Tract Infections: a Multicentre Randomised Trial","CHOICE UTI","Inclusion Criteria:\n\n* 3 months (corrected age) to 18 years\n* Fever (reported fever at home or measured fever of ≥38 degrees Celsius associated with the illness that triggered current ED presentation (eg fever may have been 18 hours prior to presentation but none since then because patient has been on maximal antipyretics - paracetamol or ibuprofen)\n* Any of the following complicating features: Vomiting, Rigors, History of recurrent UTI, Urological abnormalities, Tachycardia\n* Urine sample available (Urine culture must have been collected prior to or within an hour of antibiotic treatment, either at the GP or ED - in order to assess urine culture as per below).\n* Abnormal urinary dipstick leucocyte esterase \\>1+ or nitrite positive OR ≥5 White Blood Cells (WBCs) per high-power field in centrifuged urine OR≥ 10 White Blood Cells (WBCs) per mm3 in uncentrifuged urine and bacteriuria with any bacteria per high-power field\n* ED clinician determines the child requires treatment with IV antibiotics \\* In ED, only urine dipstick or urinalysis will be available. Once urine culture is available, to be included in the efficacy analysis, culture results must meet the following criteria: Positive urine culture result with no more than 2 species of microorganisms AND Spontaneously voided urine with ≥105 microorganisms per mL of urine or Suprapubic aspirate or urinary catheter with ≥104 microorganisms per mL of urine. In the absence of a positive urine culture, ultrasonographic findings supporting pyelonephritis (per reporting radiologist) will be accepted as evidence of a urinary tract infection.\n\nExclusion Criteria:\n\n* Sepsis (requiring inotropic support or more than 20ml\u002Fkg of fluid bolus in Emergency Department)\n* Known allergy to all once daily study drug options (gentamicin or ceftriaxone or amikacin)\n* If the patient has another co-existing condition which requires (based on established evidence-based guidelines) more than 1 dose of IV antibiotics eg meningitis\n* Known chronic renal failure or renal transplant patients\n* Unrepaired posterior urethral valves\n* Indwelling stent and fever\n* Previously enrolled participants in the CHOICE UTI trial.\n* No available oral antibiotic option for this UTI: urine culture result already available and multi-resistant organism with susceptibility only to IV antibiotics or known intolerance to oral antibiotics (previous UTI with multi-resistant organism not an exclusion)\n* Previous IV antibiotics for same UTI episode eg interhospital transfer whereby significant time has passed since first dose IV\n* Patients with clinically suspected renal abscess e.g., extreme renal tenderness, out of keeping with pyelonephritis (clinically determined).\n* Clinician does not intend on prescribing a course of IV antibiotics but plans on only giving a single dose from the outset\n* Recurrence of urinary tract infection within 2 weeks\n* Unable to obtain consent\n* Patient is pregnant","3 Months",{"count":50,"type":20},452,[52],"PHASE4","Urinary tract infections (UTI) are commonly encountered in children, with 7% diagnosed with at least one UTI by the age of 19 years. The evidence for treatment of uncomplicated UTI is clear; oral antibiotics are as good as intravenous (IV) antibiotics, usually for a total of 7 days. Complicated UTIs (cUTIs) on the other hand, are common reasons for hospital admissions for IV antibiotics and constitute a major burden for healthcare systems. There is considerable variation in care for children who present with UTI and have complicating features such as vomiting, dehydration, urological abnormalities or have a previous history of UTI. Australian and international guidelines lack clear, evidence-based recommendations to guide treatment in this group. Without gold standard evidence, these children will continue to receive unnecessary IV antibiotics, longer hospital stays and poorer health outcomes.\n\nThis multicentre, non-inferiority randomised trial will investigate if One dose - single dose of IV followed by 2 days oral antibiotics is as non-inferior to Three doses for children with UTI and co-existing complicating factors presenting to the Emergency Department (ED). In other words, this study will compare if a single dose of IV antibiotics plus two days oral antibiotics is as clinically effective as 3 doses antibiotics in resolving UTI symptoms at 72 hours after the first dose of IV antibiotics, for complicated UTIs in children presenting to the ED. All participants will receive a total of 7 days of antibiotics for the complicated urinary tract infection. If 1 dose IV and 2 days oral antibiotics is found to be as good as 3 days, the duration of IV antibiotics for complicated UTI can be reduced along with avoidance of the inherent risks of unnecessary hospital admission by administering a single IV dose in an outpatient\u002FED setting. On the other hand if a single IV dose results in prolonged symptoms or treatment failure, this will inform practice for the proportion of children who have a single dose of IV antibiotics in the ED and are sent home on oral antibiotics. Regardless of the outcome, this trial will inform clinical practice for complicated UTI to improve health outcomes for this group.",[26,55,56],"Infection","Pediatric Infectious Disease","2026-07-06",{"date":59,"type":31},"2026-07-08",{"date":61,"type":31},"2022-05-30",{"date":63,"type":20},"2028-05-16",{"name":65,"class":66},"Murdoch Childrens Research Institute","OTHER",7,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100495584","a-study-to-learn-about-the-study-medicine-zavicefta-after-it-is-released-into-the-markets-in-korea-100495584","NCT05733104","A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea","Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV","1. Adults and paediatric patients aged 3 months and older, who have been administered at least one dose of Zavicefta for the treatment of one of the indications as follows:\n\n   * Complicated intra-abdominal infection (cIAI)\n   * Complicated urinary tract infection (cUTI), including pyelonephritis\n   * Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)\n   * Other aerobic Gram-negative organism infection with limited treatment options\n2. Adults 19 years of age or older, who have been administered at least one dose of Zavicefta for the treatment of the indication as follows:\n\n   •Bacteremia associated with or suspected to be associated with cIAI, cUTI or HAP including VAP.\n3. Patients are treated with Zavicefta for the first time\n4. Patients have signed the data privacy statement.",{"count":76,"type":20},600,"OBSERVATIONAL","The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen, urinary tract and pneumonia which could have come from hospitalizations.\n\nThis study was required by the Ministry of Food and Drug Safety (MFDS) of Korea's regulations.",[80,26,81],"Complicated Intra-abdominal Infection","Hospital-acquired Pneumonia",[83,84,85,86],"Ceftazidime","Avibactam","safety","efficacy","2025-09-02",{"date":89,"type":31},"2025-09-03",{"date":91,"type":31},"2024-02-19",{"date":93,"type":20},"2029-09-28",{"name":95,"class":38},"Pfizer",1]