Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT06065267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-03
First Post:
2023-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Levofloxacin Concomitant Versus Levofloxacin Sequential
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'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': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2023-09-27', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', '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': ['Helicobacter Pylori', 'levofloxacine', 'concomitant', 'sequential'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '38225650', 'type': 'DERIVED', 'citation': 'Alhalabi M, Almokdad R. Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial. Trials. 2024 Jan 15;25(1):55. doi: 10.1186/s13063-024-07906-3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the 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': 'NCT06065267', 'briefTitle': 'Levofloxacin Concomitant Versus Levofloxacin Sequential', 'organization': {'class': 'OTHER', 'fullName': 'Damascus Hospital'}, 'officialTitle': 'Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'G-9-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sequential', 'description': 'Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen', 'interventionNames': ['Drug: sequential']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'concomitant', 'description': 'Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen', 'interventionNames': ['Drug: Levofloxacin 500Mg Oral Tablet']}], 'interventions': [{'name': 'sequential', 'type': 'DRUG', 'otherNames': ['Esomeprazole', 'levofloxacine', 'metronidazole', 'amoxicillin'], 'description': 'amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week', 'armGroupLabels': ['sequential']}, {'name': 'Levofloxacin 500Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Amoxicilline', 'Esomeprazol', 'Tinadizole'], 'description': 'Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid', 'armGroupLabels': ['concomitant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damascus', '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': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damascus Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of digestive diseases department', 'investigatorFullName': 'Marouf Alhalabi', 'investigatorAffiliation': 'Damascus Hospital'}}}}