Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT04626193
Status:
UNKNOWN
Last Update Posted:
2020-11-12
First Post:
2020-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LOAD VS Levofloxacine Concomitant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-08', 'studyFirstSubmitDate': '2020-11-08', 'studyFirstSubmitQcDate': '2020-11-08', 'lastUpdatePostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate of Helicobacter pylori infection', 'timeFrame': '8 week from begning of treatment', 'description': 'Eradication rate of Helicobacter infected patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Doxycycline', 'LOAD regimen', 'Helicobacter Pylori', 'levofloxacine', 'tinadizole'], 'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:\n* Positive rapid urease test (CLOtest).\n* Histologic evidence of H. pylori by modified Giemsa staining.\n* Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.\n\nExclusion Criteria:\n\n* Children and teenagers aged less than 18 years.\n* Previous eradication treatment for H. pylori.\n* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.\n* History of gastrectomy.\n* Gastric malignancy, including adenocarcinoma and lymphoma,\n* Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,\n* Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).\n* Contraindication to treatment drugs.\n* Pregnant or lactating women.\n* Severe concurrent disease.\n* Liver cirrhosis.'}, 'identificationModule': {'nctId': 'NCT04626193', 'briefTitle': 'LOAD VS Levofloxacine Concomitant', 'organization': {'class': 'OTHER', 'fullName': 'Damascus Hospital'}, 'officialTitle': 'Comparing the Efficacy of Two Weeks Therapy of Doxycycline,Levofloxacin,Tinidazole Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population', 'orgStudyIdInfo': {'id': 'G-10-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Doxycyclien', 'description': 'Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levofloxacine', 'description': 'Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline', 'interventionNames': ['Drug: Levofloxacin 500mg']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Tinadizole', 'Esomeprazole', 'levofloxacine'], 'description': 'Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid', 'armGroupLabels': ['Doxycyclien']}, {'name': 'Levofloxacin 500mg', 'type': 'DRUG', 'otherNames': ['Amoxicilline', 'Esomeprazol', 'Tinadizole'], 'description': 'Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid', 'armGroupLabels': ['Levofloxacine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', 'status': 'RECRUITING', 'country': 'Syria', 'contacts': [{'name': 'Marouf MI Alhalabi, MD', 'role': 'CONTACT', 'email': 'e.marouf@hotmail.com', 'phone': '+963952781278'}], 'facility': 'General Assembly of Damascus Hospital', 'geoPoint': {'lat': 33.5102, 'lon': 36.29128}}], 'centralContacts': [{'name': 'Marouf MH Alhalabi, MD', 'role': 'CONTACT', 'email': 'e.marouf@hotmail.com', 'phone': '+963952781278'}], 'overallOfficials': [{'name': 'Marouf M Alhalabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'general assambly of damascus hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Within 5 year of study completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of digestive diseases department', 'investigatorFullName': 'Marouf Alhalabi', 'investigatorAffiliation': 'Damascus Hospital'}}}}