Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yi Yang
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

1. Age 18-65 years.

2. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)

3. mRS≤2 before stroke onset, NIHSS≥5 after intravenous thrombolysis

4. Signed and dated informed consent is obtained

5. Levofloxacin/simulant treatment initiated within 24h of intravenous thrombolysis

Exclusion Criteria:

1. 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;

2. 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;

3. 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;

4. Ion disorders: hyponatremia (Na<130mmol/L), hypokalemia (K<3.5mmol/L), hyperkalemia (K>5.5mmol/L);

5. Fasting blood glucose lower than 3.9 mmol/L;

6. Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization;

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.