Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT07274020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-10-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exacerbation frequency', 'timeFrame': '12 months', 'description': 'Number of acute bronchiectasis exacerbations per patient during follow-up'}], 'secondaryOutcomes': [{'measure': 'Microbiological clearance', 'timeFrame': '12 months', 'description': 'Rate of clearance of Pseudomonas aeruginosa and other pathogens from sputum cultures'}, {'measure': 'Change in FVC', 'timeFrame': 'Baseline and 12 months', 'description': 'Change in Forced vital capacity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis, Non-Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Bronchiectasis is a chronic respiratory disease characterized by recurrent infections, inflammation, and progressive lung damage. Frequent exacerbations are associated with increased morbidity, accelerated lung function decline, and reduced quality of life. Preventing exacerbations is a key therapeutic goal. Moxifloxacin, a fluoroquinolone antibiotic with broad-spectrum activity, may play a role in intermittent eradication therapy to reduce bacterial load, achieve microbiological clearance, and minimize exacerbation frequency.\n\nThis randomized controlled trial will evaluate the effectiveness and safety of long-term intermittent moxifloxacin therapy compared with standard care in patients with non-cystic fibrosis bronchiectasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* Confirmed diagnosis of non-cystic fibrosis bronchiectasis by high-resolution CT (HRCT).\n* History of ≥2 bronchiectasis exacerbations in the previous 12 months.\n\nExclusion Criteria:\n\n* Diagnosis of cystic fibrosis-related bronchiectasis.\n* Known hypersensitivity or contraindication to fluoroquinolones (including moxifloxacin).\n* Severe hepatic impairment or severe renal impairment (eGFR \\<30 mL/min/1.73 m²).\n* Pregnancy or breastfeeding.\n* History of significant QT prolongation, arrhythmia, or concurrent use of QT-prolonging drugs.\n* Use of long-term suppressive antibiotics for bronchiectasis in the past 3 months.'}, 'identificationModule': {'nctId': 'NCT07274020', 'briefTitle': 'Long-Term Safety and Efficacy of Moxifloxacin in Bronchiectasis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effectiveness and Safety of Long-Term Intermittent Moxifloxacin Eradication Therapy in Non-Cystic Fibrosis Bronchiectasis: A 12-Month Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ASSIUT-CH-MOXI-BE-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermittent Moxifloxacin + Standard Care', 'description': 'Participants will receive moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months) in addition to guideline-based standard care', 'interventionNames': ['Drug: Intermittent Moxifloxacin + Standard Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care (Control)', 'description': 'Participants will receive guideline-based standard care without long-term suppressive antibiotics.', 'interventionNames': ['Other: Standard Care (in control arm)']}], 'interventions': [{'name': 'Intermittent Moxifloxacin + Standard Care', 'type': 'DRUG', 'description': 'Moxifloxacin 400 mg orally once daily for 7 days every 8 weeks (total 6 cycles over 12 months), in addition to guideline-based standard care', 'armGroupLabels': ['Intermittent Moxifloxacin + Standard Care']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': 'Participants will receive guideline-based management of bronchiectasis without long-term suppressive antibiotics.', 'armGroupLabels': ['Standard Care (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'state': 'Asyut Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Montaser Gamal Elddin, Lecturer', 'role': 'CONTACT', 'email': 'Montaser_zahran@yahoo.com', 'phone': '+21008951058'}], 'facility': 'Assiut University hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'montaser gamal ahmed, lecturer', 'role': 'CONTACT', 'email': 'montaser_zahran@yahoo.com', 'phone': '+201008951058'}], 'overallOfficials': [{'name': 'montaser gamal ahmed, gamal ahmed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Chest Diseases and Tuberculosis', 'investigatorFullName': 'Montaser Gamal Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}