Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Acute Ischemic Stroke
In brief
The purpose of this study is to determine the efficacy and safety of levofloxacin in treating acute ischemic stroke.
Key facts
- Study ID
- NCT05799326
- Run by
- Yi Yang
- People needed
- 100
- Starts
- 2023-06-30
- Expected to finish
- 2024-12-30
- Last updated by the study team
- 2024-10-02
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-75 years.
- 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.
- mRS≤1 before stroke onset.
- Signed and dated informed consent is obtained.
You may not qualify if…
- Patients with transient ischemic attack and those undergoing emergency reperfusion therapy, including intravenous thrombolysis and emergency thrombectomy.
- 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.
- 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.
- 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.
- Concurrent infection.
- Blood glucose lower than 3.9 mmol/L.
- Patients allergy to fluoroquinolones or other antibiotics.
- Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons.
- Not willing to be followed up or poor treatment compliance.
- 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.
- Other conditions not suitable for enrollment.
Where it is running
- First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
Full record on ClinicalTrials.gov
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