[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100455127":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":71,"collaborators":38,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":38,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":38,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":38,"overallStatus":55,"whyStopped":38,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Symptomatic Patients with low Colony Count","Patients with positive urinalysis, symptomatic, and Urine Culture Colony Count \\\u003C10,000 to be treated based on Next Generation Sequencing result.",[12,13],"Drug: Antibiotic","Device: Next Gen",[15,33],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Antibiotic","FDA approved and marketed antibiotic treatment for the patients with UTI symptoms and CC \\>0 and \\\u003C10,000",[9],[21,22,23,24,25,26,27,28,29,30,31,32],"Ampicillin\u002FAmoxicillin","Antifolates","Cephalosporins","Clindamycin","Extended spectrum penicillins","Fluoroquinolones","Fosfomycin","Linezolid","Metronidazole","Nitrofurantoin","Penicillins","Tetracyclines",{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Next Gen","Next Generation Sequencing (NGS) is available to detect bacteria in urine based on bacterial genomes.",[9],null,[40],{"name":41,"affiliation":42,"role":43},"Majid Mirzazadeh, MD","Wake Forest Health Sciences","PRINCIPAL_INVESTIGATOR",[45,49],{"name":41,"role":46,"phone":47,"phoneExt":38,"email":48},"CONTACT","336-716-4310","mmirzaza@wakehealth.edu",{"name":50,"role":46,"phone":51,"phoneExt":38,"email":52},"Sachin N Vyas, MS, PhD","336-713-4098","sachin.vyas@advocatehealth.org",[54],{"facility":42,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Winston-Salem","North Carolina","27157","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-80.24422,36.09986,{"lat":65,"lon":64},[68,69,70],{"name":41,"role":46,"phone":47,"phoneExt":38,"email":48},{"name":50,"role":46,"phone":51,"phoneExt":38,"email":52},{"name":41,"role":43,"phone":38,"phoneExt":38,"email":38},{"type":72,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100455127","phase-4-nextgen---clinical-implication-of-next-generation-sequencing-100455127",false,"NCT05206500","NextGen - Clinical Implication of Next Generation Sequencing","Clinical Implication of Next Generation Sequencing of Urinary Bacteria in Patients With Low Colony Forming Units of Bacteria in Traditional Urine Culture","Inclusion Criteria:\n\n* Female at least 18 years of age\n* U\u002FC (Urinary Culture) growth of \\\u003C10,000 Colony-Forming Units (CFU)\n* Understanding and acceptance of the need to return for all scheduled follow-up visits\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Catheter in use (Foley or suprapubic or intermittent)\n* Not able to provide clean midstream urine\n* Antibiotic consumption in the past 2 weeks before signing the consent\n* Pregnant or Planning to Conceive\n* Incarcerated","FEMALE","18 Years","80 Years",{"count":84,"type":85},100,"ESTIMATED","INTERVENTIONAL",[88],"PHASE4","Recently more advanced techniques, including Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) are available to detect bacteria in urine based on bacterial genomes. Comparing to traditional culture, these techniques have more sensitivity and could potentially be of a great help in patients with Colony Count of less than 10,000 and more than zero.",[91],"Urinary Tract Infections","2025-12-01",{"date":94,"type":95},"2025-12-08","ACTUAL",{"date":97,"type":95},"2022-05-17",{"date":99,"type":85},"2028-12",{"name":5,"class":6},1]