Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2026-01-01 @ 10:44 AM
Study NCT ID:
NCT04879992
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D013752', 'term': 'Tetracycline'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 413}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradication rate', 'timeFrame': 'Six weeks after completion of therapy', 'description': 'Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was'}], 'secondaryOutcomes': [{'measure': 'Compliance rate', 'timeFrame': 'Within 7 days after completion of therapy', 'description': 'Compliance was defined as poor when they had taken less than 80% of the total medication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori Therapy'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '37079894', 'type': 'DERIVED', 'citation': 'Chen J, Guo Y, Huang Y, Ding Z, Wang J, Liang X, Xu P, Han Y, Lu H. Rifabutin-Containing Triple Therapy Versus Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Multicenter, Randomized Controlled Trial. J Infect Dis. 2023 Aug 31;228(5):511-518. doi: 10.1093/infdis/jiad114.'}]}, 'descriptionModule': {'briefSummary': 'Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ability and willingness to participate in the study and to sign and give informed consent\n* Confirmed H. pylori infection and with previous treatment experience\n\nExclusion Criteria:\n\n* Less than 18 years old\n* With previous gastric surgery\n* Previous history of tuberculosis\n* Major systemic diseases\n* Pregnancy or lactation\n* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion'}, 'identificationModule': {'nctId': 'NCT04879992', 'briefTitle': 'Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'rjcjn20210506'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tetracycline Bismuth Quadruple Therapy', 'description': 'Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid', 'interventionNames': ['Drug: Esomeprazole', 'Drug: Bismuth Potassium Citrate', 'Drug: Tetracycline,Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'rifabutin triple therapy', 'description': 'Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid', 'interventionNames': ['Drug: Esomeprazole', 'Drug: amoxicillin rifabutin']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor', 'armGroupLabels': ['Tetracycline Bismuth Quadruple Therapy', 'rifabutin triple therapy']}, {'name': 'Bismuth Potassium Citrate', 'type': 'DRUG', 'description': 'Gastric mucosal protective drug with anti-H. pylori effect', 'armGroupLabels': ['Tetracycline Bismuth Quadruple Therapy']}, {'name': 'Tetracycline,Metronidazole', 'type': 'DRUG', 'description': 'Antibiotics for H. pylori eradication', 'armGroupLabels': ['Tetracycline Bismuth Quadruple Therapy']}, {'name': 'amoxicillin rifabutin', 'type': 'DRUG', 'description': 'Antibiotics for H. pylori eradication', 'armGroupLabels': ['rifabutin triple therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine', 'investigatorFullName': 'Hong Lu, MD', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}