Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-29 @ 3:48 PM
Study NCT ID:
NCT05173493
Status:
COMPLETED
Last Update Posted:
2023-02-17
First Post:
2021-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study About 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': 'D005664', 'term': 'Furazolidone'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'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': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'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': 670}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2021-12-28', 'studyFirstSubmitQcDate': '2021-12-28', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The most suitable re-eradication time', 'timeFrame': '6 months', 'description': 'The most suitable re-eradication time（The unit is month） will be assessed by paired comparison method .'}], 'secondaryOutcomes': [{'measure': 'Eradication rates in three groups', 'timeFrame': '6months', 'description': 'Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in three groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Re-eradication time', 'Remedial treatment'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '40304303', 'type': 'DERIVED', 'citation': 'Lin M, Hu J, Liu J, Wang J, Han Z, Wang X, Zhai Z, Yu Y, Yuan W, Zhang W, Wang Z, Kong Q, Lin B, Ding Y, Wan M, Zhang W, Duan M, Zeng S, Li Y, Zuo X, Li Y. The interval of rescue treatment does not affect the efficacy and safety of Helicobacter pylori eradication: A prospective multicenter observational study. Chin Med J (Engl). 2025 Jun 20;138(12):1439-1446. doi: 10.1097/CM9.0000000000003534. Epub 2025 Apr 29.'}]}, '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. At 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 inpatients 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': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-70 with H. pylori infection.\n* Patients with previous Helicobacter pylori eradication.\n\nExclusion Criteria:\n\n* Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks.\n* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.\n* Patients with known or suspected allergy to study medications.\n* Currently pregnant or lactating.\n* Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.'}, 'identificationModule': {'nctId': 'NCT05173493', 'briefTitle': 'The Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'The Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure', 'orgStudyIdInfo': {'id': '2021-SDU-QILU-G101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amoxicillin-Furazolidone-containing quadruple group', 'description': 'Patients in amoxicillin-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.', 'interventionNames': ['Drug: Amoxicillin,Furazolidone']}, {'label': 'Amoxicillin-Levofloxacin-containing quadruple group', 'description': 'Patients in amoxicillin-Levofloxacin-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.', 'interventionNames': ['Drug: Amoxicillin,Levofloxacin']}, {'label': 'Tetracycline-Furazolidone-containing quadruple group', 'description': 'Patients in tetracycline-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), tetracycline 500 mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.', 'interventionNames': ['Drug: Tetracycline,Furazolidone']}], 'interventions': [{'name': 'Amoxicillin,Furazolidone', 'type': 'DRUG', 'description': 'Amoxicillin-Furazolidone-containing quadruple group', 'armGroupLabels': ['Amoxicillin-Furazolidone-containing quadruple group']}, {'name': 'Amoxicillin,Levofloxacin', 'type': 'DRUG', 'description': 'Amoxicillin-Levofloxacin-containing quadruple group', 'armGroupLabels': ['Amoxicillin-Levofloxacin-containing quadruple group']}, {'name': 'Tetracycline,Furazolidone', 'type': 'DRUG', 'description': 'Tetracycline-Furazolidone-containing quadruple group', 'armGroupLabels': ['Tetracycline-Furazolidone-containing quadruple group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Xiuli Zuo', '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 hospita', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}