Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT03413020
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2018-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tailored Therapy for Helicobacter Pylori Rescue Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D064704', 'term': 'Levofloxacin'}], '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': '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': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-05', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medical cost per patient of tailored therapy', 'timeFrame': 'Two months after completion of therapy'}], '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 defined as negative result from urea breath test (\\<4‰) (4‰ as the cutoff value).'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse effects', 'timeFrame': 'Within 7 days after completion of therapy', 'description': 'The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities).'}, {'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', 'Rescue therapy', 'Tailored therapy', 'Antimicrobial susceptibility testing'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '31523279', 'type': 'DERIVED', 'citation': 'Yu L, Luo L, Long X, Liang X, Ji Y, Chen Q, Song Y, Li X, Graham DY, Lu H. Susceptibility-guided therapy for Helicobacter pylori infection treatment failures. Therap Adv Gastroenterol. 2019 Sep 9;12:1756284819874922. doi: 10.1177/1756284819874922. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'With increasing antibiotic resistance and unsatisfactory results of empiric eradication regimens, tailored therapy may be the best choice to achieve high efficacy for rescue treatment. This study aimed to evaluate the eradication rates, safety, and compliance of antimicrobial susceptibility-based tailored therapy for rescue treatment in patients with Helicobacter pylori infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease\n* Previous failures of H. pylori eradication therapy and need rescue therapy\n* Ability and willingness to participate in the study and to sign and give informed consent\n* Confirmed H. pylori infection\n\nExclusion Criteria:\n\n* Less than 18 years old\n* With previous gastric surgery\n* Major systemic diseases\n* Pregnancy or lactation\n* Allergy to any of the study drugs\n* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion'}, 'identificationModule': {'nctId': 'NCT03413020', 'briefTitle': 'Tailored Therapy for Helicobacter Pylori Rescue Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Efficacy of Tailored for Helicobacter Pylori Rescue Treatment Based on Antimicrobial-susceptibility Testing', 'orgStudyIdInfo': {'id': 'rjkls2017198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Therapy', 'description': 'After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole, amoxicillin and one sensitive of clarithromycin, metronidazole and levofloxacin.If isolates were resistant to all three tested antibiotics, give esomeprazole, bismuth potassium citrate, metronidazole and amoxicillin for 14 days.', 'interventionNames': ['Drug: esomeprazole', 'Drug: bismuth Potassium Citrate', 'Drug: amoxicillin', 'Drug: clarithromycin', 'Drug: metronidazole', 'Drug: levofloxacin']}], 'interventions': [{'name': 'esomeprazole', 'type': 'DRUG', 'description': 'proton pump inhibitor', 'armGroupLabels': ['Tailored Therapy']}, {'name': 'bismuth Potassium Citrate', 'type': 'DRUG', 'description': 'gastric mucosal protective drug with anti-H. pylori effect', 'armGroupLabels': ['Tailored Therapy']}, {'name': 'amoxicillin', 'type': 'DRUG', 'description': 'antibiotic for H. pylori eradication', 'armGroupLabels': ['Tailored Therapy']}, {'name': 'clarithromycin', 'type': 'DRUG', 'description': 'antibiotic for H. pylori eradication', 'armGroupLabels': ['Tailored Therapy']}, {'name': 'metronidazole', 'type': 'DRUG', 'description': 'antibiotic for H. pylori eradication', 'armGroupLabels': ['Tailored Therapy']}, {'name': 'levofloxacin', 'type': 'DRUG', 'description': 'antibiotic for H. pylori eradication', 'armGroupLabels': ['Tailored 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}}], 'overallOfficials': [{'name': 'Hong Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, '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'}}}}