[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06808451":3,"trial-entities:NCT06808451":110,"trial-summary:NCT06808451":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":49,"sex":65,"minimum_age":66,"maximum_age":17,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":83,"locations":86,"central_contacts":102,"overall_officials":104,"references":108,"see_also_links":109},"NCT06808451","STUDY20241345","Diagnosis and Treatment of Urinary Tract Infection Using DNA Polymerase Chain Reaction Versus Urine Culture","Diagnosis and Treatment of Urinary Tract Infection Using DNA PCR Versus Urine Culture - A Randomized Controlled Trial","RECRUITING","2026-09-30","2026-03","2026-03-11","2025-10-22","University Hospitals Cleveland Medical Center","OTHER",true,"Adults 18 years or older with urinary tract infection (UTI) symptoms. Participants will be assigned to either the urine culture group or the DNA PCR study group by randomization. At time of enrollment in the study they will be also asked to fill out two questionnaires. If prescribed antibiotics for treatment of a UTI, participants will then be called the day after they are scheduled to stop their antibiotics. Participants will be asked to fill out questionnaires the day after finishing antibiotics. Participants will be enrolled in the study for a maximum of 21 days.",null,[19],"Urinary Tract Infections",[21,22],"urine culture","DNA PCR","INTERVENTIONAL","DIAGNOSTIC",[26],"NA",{"count":28,"type":29},136,"ESTIMATED",[31,36],{"type":32,"name":22,"description":33,"armGroupLabels":34},"DEVICE","Gene analysis with PCR will be conducted from the urine samples of the patients with acute UTI symptoms.",[35],"DNA Polymerase Chain Reaction (PCR)",{"type":37,"name":38,"description":39,"armGroupLabels":40},"DIAGNOSTIC_TEST","Urine Culture","Urine samples of the patients with acute UTI symptoms will be sent to the UH lab for routine urine culture.",[38],[42,46],{"measure":43,"description":44,"timeFrame":45},"Change in symptoms as measured by UTI-SIQ-8 questionnaire","The UTI-SIQ-8 is an eight item questionnaire that asks about symptom severity and symptom impairment on a likert scale from 0 to 4, 0 being not at all and 4 being very strong\u002Fvery severe.","Baseline, one day after antibiotic completion",{"measure":47,"description":48,"timeFrame":45},"Change in symptoms as measured by the UTI Symptom Assessment questionnaire","The UTI Symptom Assessment questionnaire is a ten item questionnaire that asks about symptom relief, with lower scores indicating less symptoms.",[50,53,55,58,61,63],{"measure":51,"timeFrame":52},"Length of time from patient presentation to initiation of treatment as measured by medical record review","Up to 21 days",{"measure":54,"timeFrame":52},"Number of antibiotic changes as measured by medical record review",{"measure":56,"description":57,"timeFrame":52},"Duration of antibiotic use as measured by medical record review","Duration will be measured in days",{"measure":59,"description":57,"timeFrame":60},"Number of times participant represents with UTI symptoms as measured by medical record review","Up to 30 days",{"measure":62,"timeFrame":52},"Number of additional diagnostic procedures related to initial presenting symptoms as measured by medical record review",{"measure":64,"timeFrame":52},"Number of hospitalizations related to UTI as measured by medical record review","ALL","18 Years",false,{"inclusion":69,"exclusion":73,"raw_text":82},[70,71,72],"Adult men and women 18 years and older","Presenting to clinic with symptoms of UTI or cystitis","Patients with Medicare and Medicaid insurance",[74,75,76,77,78,79,80,81],"Urinary diversion of any type","Chronic indwelling urinary catheter","Diagnosed UTI within the previous 21 days","Antibiotic therapy within the previous 21 days","Use of phenazopyridine within the previous 21 days","Commercial insurance","Non-English speaking","Pregnant patients","Inclusion Criteria:\n\n* Adult men and women 18 years and older\n* Presenting to clinic with symptoms of UTI or cystitis\n* Patients with Medicare and Medicaid insurance\n\nExclusion Criteria:\n\n* Urinary diversion of any type\n* Chronic indwelling urinary catheter\n* Diagnosed UTI within the previous 21 days\n* Antibiotic therapy within the previous 21 days\n* Use of phenazopyridine within the previous 21 days\n* Commercial insurance\n* Non-English speaking\n* Pregnant patients",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":99},"University Hospitals","Cleveland","Ohio","44106","United States",[94],{"name":95,"role":96,"phone":97,"email":98},"Diana N Mitchell, MD, MBA, BSN","CONTACT","216-844-1000","diana.mitchell@uhhospitals.org",{"lat":100,"lon":101},41.4995,-81.69541,[103],{"name":95,"role":96,"phone":97,"email":98},[105],{"name":106,"affiliation":88,"role":107},"David Sheyn, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[112],"Urinary Tract Infection",[],{"nct_id":4,"found":15,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This interventional study will randomly assign 136 adult participants to either the DNA PCR or urine culture group. The study phase is not specified.","completed","Diagnosing and Treating UTIs: DNA PCR vs. Urine Culture","This study is comparing two ways to diagnose urinary tract infections (UTIs): DNA PCR (a gene analysis test) and standard urine culture. Researchers want to see which method better helps improve your UTI symptoms. You may be able to join if you are an adult (18 or older) experiencing UTI symptoms and have Medicare or Medicaid insurance. You cannot join if you've had a recent UTI or antibiotic treatment. The study will measure how much your symptoms change using two questionnaires, completed at the start and again one day after you finish any prescribed antibiotics. The study status is unclear, and it plans to enroll 136 participants.","You will be followed up one day after completing antibiotic treatment to assess symptom changes.",107,"You will complete two questionnaires at the start of the study. If you receive antibiotics for a UTI, you will complete the questionnaires again one day after finishing them. Your participation will last a maximum of 21 days.","Not stated in the trial record.",[22,38],"v2"]