Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke
NCT ID: NCT05799326
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-06-30
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Levofloxacin group
Levofloxacin 200mg twice per day is administrated.
Levofloxacin
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.
Levofloxacin simulant group
Levofloxacin simulant 200mg twice per day is administrated.
Levofloxacin simulant
Levofloxacin simulant is placebo.
Interventions
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Levofloxacin
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.
Levofloxacin simulant
Levofloxacin simulant is placebo.
Eligibility Criteria
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Inclusion Criteria
2. The patients were clinically diagnosed with acute ischemic stroke with NIHSS score ≥5 points and ≤15 points,and NHISS score 1a level of consciousness \< 1 point.
3. mRS≤1 before stroke onset.
4. Signed and dated informed consent is obtained.
Exclusion Criteria
2. 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.
3. 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.
4. 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.
5. Concurrent infection.
6. Blood glucose lower than 3.9 mmol/L.
7. Patients allergy to fluoroquinolones or other antibiotics.
8. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons.
9. Not willing to be followed up or poor treatment compliance.
10. 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.
11. Other conditions not suitable for enrollment.
18 Years
75 Years
ALL
No
Sponsors
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Yi Yang
OTHER
Responsible Party
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Yi Yang
Associated Dean of First Hospital of Jilin University
Principal Investigators
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Yi Yang, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LVX-AIS
Identifier Type: -
Identifier Source: org_study_id
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