Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05741905
Status:
RECRUITING
Last Update Posted:
2024-10-02
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2023-02-06', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'National Institute of Health stroke scale (NIHSS)', 'timeFrame': 'in 24 hours of intravenous thrombolysis', 'description': 'NIHSS ranged from 0 to 42, a low value represents a better outcome'}, {'measure': 'NIHSS at discharge/7 days', 'timeFrame': 'discharge/7 days', 'description': 'NIHSS ranged from 0 to 42, a low value represents a better outcome'}], 'secondaryOutcomes': [{'measure': 'Hemorrhagic transformation and symptomatic intracranial hemorrhage', 'timeFrame': '24h,3 days and discharge/7 days', 'description': 'defined by computed tomography (CT) brain scan showed bleeding and a concomitant increase in National Institute of Health stroke scale (NIHSS) score of ≥4 points.'}, {'measure': 'Infarct volume after 3 days of Levofloxacin/simulant treatment', 'timeFrame': 'Immediately after 3 days of Levofloxacin/simulant treatment', 'description': 'assessed by magnetic resonance imaging brain scan'}, {'measure': 'Modified rankin scale (mRS) score at 30 days', 'timeFrame': '30 days', 'description': 'mRS ranged from 0 to 6, a low value represents a better outcome'}, {'measure': 'mRS score at 90 days', 'timeFrame': '90 days', 'description': 'mRS ranged from 0 to 6, a low value represents a better outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'Intravenous thrombolysis', 'Levofloxacin'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke', 'detailedDescription': "Acute ischemic stroke is a leading cause of disability and mortality. Intravenous thrombolysis is a major therapy for acute ischemic stroke, however, nearly half of patients failed to benefit from it. It is necessary to find new interventions combined to intravenous thrombolysis, which promote the efficacy of intravenous thrombolysis. The investigators' previous studies suggested levofloxacin to be a newly identified neuro-protective agent, which could reduce infarct volume and improve neurologic function in animal models. To evaluate the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)\n3. mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15，la (NIHSS) level of consciousness \\< 1\n\nExclusion Criteria:\n\n1. Endovascular treatment\n2. Patients using glucocorticoids, antiarrhythmic drugs (class I and class III antiarrhythmic drugs: quinidine, procaine amine, lidocaine, phenytoin sodium, verapamil, etc.), and quinolones within 14 days;\n3. Patients with other diseases that may aggravate adverse drug reactions, such as ventricular arrhythmias, prolonged QT interval (male: QTc\\>430ms, female: QTc\\>450ms), severe cardiac insufficiency (NYHA functional grade ≥ III), myasthenia gravis, peripheral neuropathy, seizures, tendon-related diseases, severe immune system-related diseases, hematological diseases, active hepatitis or cirrhosis, serious respiratory diseases;\n4. Abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamic pyruvic transaminase exceeds 3 times the upper limit of normal; Direct bilirubin or indirect bilirubin more than 3 times the normal upper limit; Blood creatinine exceeds 1.1 times the upper limit of normal; Creatinine clearance rate≤50ml/min; Urea nitrogen≥ 20mg/dL;\n5. Concurrent infection;\n6. Fasting blood glucose lower than 3.9 mmol/L;\n7. Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization;\n8. Patients allergy to fluoroquinolones or other antibiotics;\n9. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons;\n10. Not willing to be followed up or poor treatment compliance;\n11. Patients who are participating in other clinical studies, or have participated in other clinical studies within 3 months before enrollment, or have participated in this study;\n12. Other conditions not suitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT05741905', 'briefTitle': 'Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'LVX-IVT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Levofloxacin group', 'description': 'Levofloxacin 200mg twice per day is administrated.', 'interventionNames': ['Drug: Levofloxacin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Levofloxacin simulant group', 'description': 'Levofloxacin simulant 200mg twice per day is administrated.', 'interventionNames': ['Drug: Levofloxacin simulant']}], 'interventions': [{'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['Intravenous Thrombolysis'], 'description': 'Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.', 'armGroupLabels': ['Levofloxacin group']}, {'name': 'Levofloxacin simulant', 'type': 'DRUG', 'otherNames': ['Intravenous Thrombolysis'], 'description': 'Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.', 'armGroupLabels': ['Levofloxacin simulant group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Yang, MD, PhD', 'role': 'CONTACT', 'email': 'doctoryangyi@163.com', 'phone': '86-18186870008'}], 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Yi Yang, MD, PhD', 'role': 'CONTACT', 'email': 'doctoryangyi@163.com', 'phone': '13756661217', 'phoneExt': '0086'}, {'name': 'Zhen-Ni Guo, MD, PhD', 'role': 'CONTACT', 'email': 'zhen1ni2@163.com', 'phone': '18186872986', 'phoneExt': '0086'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associated Dean of First Hospital of Jilin University', 'investigatorFullName': 'Yi Yang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}