Using Levofloxacin to treat acute ischemic stroke

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

This study is testing if the antibiotic levofloxacin can help people who have had an acute ischemic stroke by reducing brain damage and improving recovery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05799326 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of levofloxacin in patients diagnosed with acute ischemic stroke. Previous research indicated that levofloxacin may serve as a neuro-protective agent, potentially reducing brain damage and improving neurological outcomes. The trial is designed as a multicenter, randomized controlled trial to rigorously assess its effects on stroke patients. Participants will receive either levofloxacin or a simulant to compare outcomes effectively.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a clinically diagnosed acute ischemic stroke and specific NIHSS scores.

Not a fit: Patients with transient ischemic attacks or those undergoing emergency reperfusion therapies will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and reduce disability in patients suffering from acute ischemic stroke.

How similar studies have performed: While the use of levofloxacin in this context is novel, previous studies have shown promise in animal models, suggesting potential for success in human trials.

Eligibility 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.

Where this trial is running

Changchun, Jilin

• First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Yi Yang, PhD — The First Hospital of Jilin University
• Study coordinator: Yi Yang, PhD

Conditions Acute Ischemic Stroke; Acute ischemic stroke; Levofloxacin