[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572265":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":10,"centralContacts":52,"locations":58,"responsibleParty":74,"collaborators":10,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":10,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":10,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":10,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Shandong University","OTHER",[8,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Unsuccessful culture attempts group",null,"Bismuth-containing quadruple therapy (vonoprazan 20 mg bid + bismuth 0.6g bid + amoxicillin 1g bid + rifabutin 0.15g bid)",[13,14,15,16],"Drug: Bismuth","Drug: Vonoprazan","Drug: Amoxicillin","Drug: Rifabutin",{"label":18,"type":10,"description":11,"interventionNames":19},"Demonstrate sensitivity to both amoxicillin and rifabutin group",[13,14,15,16],{"label":21,"type":10,"description":22,"interventionNames":23},"Drug susceptibility testing group","Two non-resistant antibiotics are selected based on drug susceptibility testing outcomes. If a patient shows sensitivity to only one antibiotic, a combination of that sensitive antibiotic with high-dose metronidazole is administered.",[13,14,15,16,24,25],"Drug: Metronidazole","Drug: Other antibiotics",[27,32,36,40,44,48],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"DRUG","Bismuth","Bismuth 0.6g bid",[18,21,9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"Vonoprazan","vonoprazan 20mg bid",[18,21,9],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"Amoxicillin","Amoxicillin 1g bid",[18,21,9],{"type":28,"name":41,"description":42,"armGroupLabels":43,"otherNames":10},"Rifabutin","Rifabutin 0.15g bid",[18,21,9],{"type":28,"name":45,"description":46,"armGroupLabels":47,"otherNames":10},"Metronidazole","Metronidazole 400mg qid",[21],{"type":28,"name":49,"description":50,"armGroupLabels":51,"otherNames":10},"Other antibiotics","The selection of other antibiotics is based on the results of drug susceptibility testing.",[21],[53],{"name":54,"role":55,"phone":56,"phoneExt":10,"email":57},"Xiuli Zuo, MD,PhD","CONTACT","15588818685","zuoxiuli@sdu.edu.cn",[59],{"facility":60,"status":10,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Qilu Hospital of Shandong University","Jinan","Shandong","250012","China","CN",{"type":67,"coordinates":68},"Point",[69,70],116.99722,36.66833,{"lat":70,"lon":69},[73],{"name":54,"role":55,"phone":56,"phoneExt":10,"email":57},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Xiuli Zuo","Professor, Director of gastroenterology department of Qilu hospital.","100572265","efficacy-of-a-14-day-bismuth-containing-quadruple-therapy-guided-by-drug-susceptibility-testing-in-patients-with-extremely-refractory-helicobacter-pylori-infection-an-exploratory-study-100572265",false,"NCT06731023","Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study","Inclusion Criteria:\n\n1. Patients aged 18-65.\n2. Patients with H.pylori infection (Positive for rapid urease test or 13C urea breath test).\n3. Received at least two previous standard treatment protocols for Helicobacter pylori, and the application regimens included at least three low-resistance antibiotics.\n\nExclusion Criteria:\n\n1. Patients with serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.\n2. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.\n3. Patients with active gastrointestinal bleeding.\n4. Patients with a history of upper gastrointestinal surgery.\n5. Patients allergic to treatment drugs.\n6. Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks\n7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse\n8. Patients who are unwilling or incapable to provide informed consents.","ALL","18 Years","70 Years",{"count":88,"type":89},30,"ESTIMATED","OBSERVATIONAL","Helicobacter pylori (H. pylori) infection, a prevalent global infectious disease, is a significant contributor to gastric cancer and other morbidities, imposing a substantial disease burden. With the rise in antibiotic resistance, the eradication of H. pylori is encountering formidable challenges. A subset of individuals, despite undergoing multiple treatment regimens, remain unable to successfully eradicate the infection. The persistence of infection in these cases could be attributed to either the limitations of detection methods leading to false positives or to the infection by superbugs that are highly resistant to antibiotics. This study is designed to ascertain whether these patients are infected with superbugs by employing various diagnostic techniques. Additionally, it aims to assess the antibiotic resistance profiles of strains associated with extremely refractory H. pylori infections through drug susceptibility testing. Based on the identified sensitivities, the study seeks to tailor treatment protocols with bismuth-containing quadruple therapy (Containing two kinds of antibiotics: sensitive antibiotic, rifabutin or high-dose metronidazole), to explore novel therapeutic strategies for patients with highly resistant H. pylori infections.",[93],"HELICOBACTER PYLORI INFECTIONS",[95,96,97],"Helicobacter pylori","Bismuth-Containing Quadruple Therapy","Drug Susceptibility Testing","NOT_YET_RECRUITING","2024-12-16",{"date":101,"type":102},"2024-12-19","ACTUAL",{"date":104,"type":89},"2025-01-01",{"date":106,"type":89},"2026-12-31",{"name":76,"class":6},1]