Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 10:59 AM
Study NCT ID:
NCT04810793
Status:
COMPLETED
Last Update Posted:
2022-10-27
First Post:
2021-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D005664', 'term': 'Furazolidone'}, {'id': 'D013752', 'term': 'Tetracycline'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D005663', 'term': 'Furans'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 820}, 'targetDuration': '2 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-26', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-03-21', 'lastUpdatePostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The most suitable re-eradication time', 'timeFrame': '1year', 'description': 'The most suitable re-eradication time will be assessed by paired comparison method .'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Re-eradication time', 'Remedial treatment'], 'conditions': ['Helicobacter Pylori']}, 'descriptionModule': {'briefSummary': 'The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.', 'detailedDescription': 'Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer.\n\nAt present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment in patients with Hp eradication failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.\n\nExclusion Criteria:\n\n* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.'}, 'identificationModule': {'nctId': 'NCT04810793', 'briefTitle': 'The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure', 'orgStudyIdInfo': {'id': '2020-SDU-QILU-G101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group', 'description': 'Patients in amoxicillin-levofloxacin-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.', 'interventionNames': ['Drug: Amoxicillin , Levofloxacin and Esomeprazole']}, {'label': 'Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group', 'description': 'Patients in amoxicillin-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.', 'interventionNames': ['Drug: Amoxicillin , Furazolidone and Esomeprazole']}, {'label': 'Tetracycline-Furazolidone-Esomeprazole-containing quadruple group', 'description': 'Patients in tetracycline-furazolidone-esomeprazole-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.', 'interventionNames': ['Drug: Tetracycline , Furazolidone and Esomeprazole']}, {'label': 'Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group', 'description': 'Patients in amoxicillin-levofloxacin-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.', 'interventionNames': ['Drug: Amoxicillin,Levofloxacin and Vonoprazan fumarate']}, {'label': 'Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group', 'description': 'Patients in amoxicillin-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, amoxicillin 1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.', 'interventionNames': ['Drug: Amoxicillin,Furazolidone and Vonoprazan fumarate']}, {'label': 'Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group', 'description': 'Patients in tetracycline-furazolidone-vonoprazan fumarate-containing quadruple group will receive vonoprazan fumarate 20mg po bid, tetracycline 500mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.', 'interventionNames': ['Drug: Tetracycline,Furazolidone and Vonoprazan fumarate']}], 'interventions': [{'name': 'Amoxicillin , Levofloxacin and Esomeprazole', 'type': 'DRUG', 'description': 'Esomeprazole-Bismuth-Amoxicillin-Levofloxacin-containing quadruple regimens', 'armGroupLabels': ['Amoxicillin-Levofloxacin-Esomeprazole-containing quadruple group']}, {'name': 'Amoxicillin , Furazolidone and Esomeprazole', 'type': 'DRUG', 'description': 'Esomeprazole-Bismuth-Amoxicillin-Furazolidone-containing quadruple regimens', 'armGroupLabels': ['Amoxicillin-Furazolidone-Esomeprazole-containing quadruple group']}, {'name': 'Tetracycline , Furazolidone and Esomeprazole', 'type': 'DRUG', 'description': 'Esomeprazole-Bismuth-Tetracycline-Furazolidone-containing quadruple regimens', 'armGroupLabels': ['Tetracycline-Furazolidone-Esomeprazole-containing quadruple group']}, {'name': 'Amoxicillin,Levofloxacin and Vonoprazan fumarate', 'type': 'DRUG', 'description': 'Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group', 'armGroupLabels': ['Amoxicillin-Levofloxacin-Vonoprazan fumarate-containing quadruple group']}, {'name': 'Amoxicillin,Furazolidone and Vonoprazan fumarate', 'type': 'DRUG', 'description': 'Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group', 'armGroupLabels': ['Amoxicillin-Furazolidone-Vonoprazan fumarate-containing quadruple group']}, {'name': 'Tetracycline,Furazolidone and Vonoprazan fumarate', 'type': 'DRUG', 'description': 'Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group', 'armGroupLabels': ['Tetracycline-Furazolidone-Vonoprazan fumarate-containing quadruple group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '257000', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Xiuli Zuo, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taian City Central Hospital', 'class': 'OTHER'}, {'name': "Dezhou People's Hospital", 'class': 'OTHER'}, {'name': 'Weifang Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, {'name': 'Shengli Oilfield Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Director of gastroenterology department of Qilu hospital', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}