Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-03-01 @ 11:38 PM
Study NCT ID:
NCT01725906
Status:
UNKNOWN
Last Update Posted:
2017-05-08
First Post:
2012-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2012-10-31', 'studyFirstSubmitQcDate': '2012-11-08', 'lastUpdatePostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate after third line rescue therapy', 'timeFrame': '8 weeks', 'description': 'Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses.\n\n(genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status'}], 'secondaryOutcomes': [{'measure': 'eradication rates in subgroup analysis by antibiotic resistance and regimen', 'timeFrame': '8 weeks', 'description': 'eradication rate in subgroup analysis according to antibiotic resistance and treatment regimen'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genotypic resistance guided therapy'], 'conditions': ['Self Efficacy']}, 'referencesModule': {'references': [{'pmid': '29964036', 'type': 'DERIVED', 'citation': 'Liou JM, Chen PY, Luo JC, Lee JY, Chen CC, Fang YJ, Yang TH, Chang CY, Bair MJ, Chen MJ, Hsu YC, Hsu WF, Chang CC, Lin JT, Shun CT, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection. Gastroenterology. 2018 Oct;155(4):1109-1119. doi: 10.1053/j.gastro.2018.06.047. Epub 2018 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed.', 'detailedDescription': 'The primary aim of this study is to compare the regimens selected using either one of the method (1) genotypic resistance guided versus (2) medication history guided therapy. (rather than to compare the efficacy of any drugs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged greater than 20 years who have persistent H. pylori infection after at least two treatments and are willing to receive third line rescue regimens are considered eligible for enrollment.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if any one of the following criteria is present: (1) children and teenagers aged less than 20 years, (2) history of gastrectomy, (3)gastric malignancy, including adenocarcinoma and lymphoma, (4) previous allergic reaction to antibiotics (Amoxicillin, Klaricid, Cravit) and prompt pump inhibitors (esomeprazole), (5)contraindication to treatment drugs, (6) pregnant or lactating women, (7) severe concurrent disease.'}, 'identificationModule': {'nctId': 'NCT01725906', 'briefTitle': 'Genotypic Resistance Guided Therapy in Helicobacter Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Genotypic Resistance Guided Therapy in the Treatment of Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': '201202068MIC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Empirical therapy', 'description': 'selection of antibiotic according to medication history', 'interventionNames': ['Drug: empirical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Genotypic resistance guided therapy', 'description': 'selection of antibiotics according to genotypic resistance', 'interventionNames': ['Drug: Genotypic resistance guided therapy']}], 'interventions': [{'name': 'empirical therapy', 'type': 'DRUG', 'otherNames': ['selection of antibiotics according to medication history'], 'description': '1. Nexium (esomeprazole), 40mg, bid, 14 days, plus\n2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus\n3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs\n4. Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14', 'armGroupLabels': ['Empirical therapy']}, {'name': 'Genotypic resistance guided therapy', 'type': 'DRUG', 'otherNames': ['selection of antibiotic according to genotypic resistance'], 'description': '1. Nexium (esomeprazole), 40mg, bid, 14 days, plus\n2. Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus\n3. Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs\n4. Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14', 'armGroupLabels': ['Genotypic resistance guided therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jyh-Ming Liou, MD', 'role': 'CONTACT', 'email': 'dtmed046@pchome.com.tw', 'phone': '+886972651883'}, {'name': 'Ming-Shiang Wu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan Universtiy Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Yun-Lin County', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chieh-Chang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital, Yun-Lin Branch'}], 'centralContacts': [{'name': 'Jyh-Ming Liou, MD', 'role': 'CONTACT', 'email': 'dtmed046@pchome.com.tw', 'phone': '+886223123456', 'phoneExt': '63541'}], 'overallOfficials': [{'name': 'Jyh-Ming Liou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'National Taiwan University Hospital', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}