[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100388059":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"(B) Empirical therapy","EXPERIMENTAL","choose antibiotics according to drug history",[13],"Drug: ET",{"label":15,"type":16,"description":17,"interventionNames":18},"(A) Susceptibility testing guided therapy","ACTIVE_COMPARATOR","choose antibiotics according to susceptibility testing",[19],"Drug: SGT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ET","Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple\u002Fquadruple therapy or concomitant therapy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"SGT","Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple\u002Fquadruple therapy or concomitant therapy",[15],[32],{"name":33,"affiliation":5,"role":34},"Mei-Jyh Chen, MD","PRINCIPAL_INVESTIGATOR",[36,42],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Mei-Jyh Chen","CONTACT","886-2-23123456","66280","migichen@ntuh.gov.tw",{"name":43,"role":38,"phone":26,"phoneExt":26,"email":44},"Yu-Chun Huang","nneder34@gmail.com",[46],{"facility":5,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Taipei","10002","Taiwan","TW",{"type":53,"coordinates":54},"Point",[55,56],121.52639,25.05306,{"lat":56,"lon":55},[59],{"name":33,"role":38,"phone":26,"phoneExt":26,"email":26},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100388059","phase-4-susceptibility-testing-guided-versus-empirical-therapy-for-refractory-h-pylori-infection-100388059",false,"NCT04332848","Susceptibility Testing Guided Versus Empirical Therapy for Refractory H. Pylori Infection","Comparison of Susceptibility Testing Guided Versus Empirical Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial","Inclusion criteria\n\n* Adult (equal or greater than 20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled.","ALL","20 Years","90 Years",{"count":73,"type":74},360,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","Aim: Therefore, we aimed to\n\n1. compare the efficacy of susceptibility testing guided therapy vs. empirical therapy in the third-line eradication for refractory H. pylori infection\n2. assess the long-term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors.\n\nMethods: This will be a multi-center, open labeled trial\n\nPatients: 360 patients with failure to H. pylori eradication for at least two times will be enrolled Determination of antibiotic resistance of H. pylori:\n\nAgar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics.\n\nTreatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Susceptibility testing guided therapy or (B) Empirical therapy\n\nOutcome Measurement:\n\nPrimary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses.\n\nSecondary End Point: 1. Eradication rate according to per protocol analysis (PP analysis); 2. Frequency of adverse effects.",[80],"Helicobacter Pylori Infection",[82],"Helicobacter pylori,Susceptibility testing,empirical,third-line treatment","2025-08-24",{"date":85,"type":86},"2025-08-29","ACTUAL",{"date":88,"type":86},"2020-07-28",{"date":90,"type":74},"2026-12",{"name":5,"class":6},1]