Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

Last updated: October 1, 2024
Sponsor: Yi Yang
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Cerebral Ischemia

Stroke

Treatment

Levofloxacin simulant

Levofloxacin

Clinical Study ID

NCT05799326
LVX-AIS
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to determine the efficacy and safety of levofloxacin in treating acute ischemic stroke.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-75 years.

  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

Exclusion Criteria:

  1. Patients with transient ischemic attack and those undergoing emergency reperfusiontherapy, including intravenous thrombolysis and emergency thrombectomy.

  2. Patients using glucocorticoids, antiarrhythmic drugs (class I and class IIIantiarrhythmic 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 asventricular 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 immunesystem-related diseases, hematological diseases, active hepatitis or cirrhosis,serious respiratory diseases.

  4. Abnormal liver and kidney function: glutamic oxaloacetic transaminase or glutamicpyruvic transaminase exceeds 3 times the upper limit of normal; Direct bilirubin orindirect bilirubin more than 3 times the normal upper limit; Blood creatinineexceeds 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 completethe 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 inother clinical studies within 3 months before enrollment, or have participated inthis study.

  11. Other conditions not suitable for enrollment.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Levofloxacin simulant
Phase:
Study Start date:
June 30, 2023
Estimated Completion Date:
December 30, 2024

Study Description

Acute ischemic stroke is a leading cause of disability and mortality. 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 in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Connect with a study center

  • First Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

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