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NCT05799326 | RECRUITING | Acute Ischemic Stroke

Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke
Sponsor:

Y i yang

Information provided by (Responsible Party):

Y i yang

Brief Summary:

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

Condition or disease

Acute Ischemic Stroke

Intervention/treatment

Levofloxacin

Levofloxacin simulant

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial
Actual Study Start Date : 2023-06-30
Estimated Primary Completion Date : 2024-12-30
Estimated Study Completion Date : 2024-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 Criteria
  • 1. Patients with transient ischemic attack and those undergoing emergency reperfusion therapy, including intravenous thrombolysis and emergency thrombectomy.
  • 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.
Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

Location Details

NCT05799326

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Locations

RECRUITING

China, Jilin

First Hospital of Jilin University

Changchun, Jilin, China, 130000