Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

Официальное название

Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Levofloxacin
  Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.
• Препарат Levofloxacin simulant
  Levofloxacin simulant is placebo.

Первичные конечные точки

• NIHSS at discharge/7 days [Срок оценки: discharge/7 days]

Вторичные конечные точки (3)

• Infarct volume after 3 days of Levofloxacin/simulant treatment [Срок оценки: immediately after 3 days of Levofloxacin/simulant treatment]
• Modified rankin scale (mRS) score at 30 days [Срок оценки: 30 days]
• mRS score at 90 days [Срок оценки: 90 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Hospital of Jilin University — Changchun

Идентификаторы

NCT: NCT05799326 · LVX-AIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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