Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- NIHSS at discharge/7 days
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of levofloxacin in treating acute ischemic stroke.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Levofloxacin group
Levofloxacin 200mg twice per day is administrated.
干预措施: Levofloxacin (Drug)
Levofloxacin simulant group
Levofloxacin simulant 200mg twice per day is administrated.
干预措施: Levofloxacin simulant (Drug)
结局指标
主要结局
NIHSS at discharge/7 days
时间窗: discharge/7 days
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
次要结局
- Infarct volume after 3 days of Levofloxacin/simulant treatment(immediately after 3 days of Levofloxacin/simulant treatment)
- Modified rankin scale (mRS) score at 30 days(30 days)
- mRS score at 90 days(90 days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University