Combining levofloxacin with thrombolysis for treating acute ischemic stroke

Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

This study is testing if adding levofloxacin to the usual treatment for acute ischemic stroke can help patients recover better and reduce brain damage.

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: NCT05741905 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of levofloxacin when used alongside intravenous thrombolysis in patients suffering from acute ischemic stroke. Acute ischemic stroke is a significant cause of disability and mortality, and while thrombolysis is a common treatment, many patients do not benefit from it. The researchers hypothesize that levofloxacin may act as a neuro-protective agent, potentially reducing brain damage and improving recovery outcomes. This multicenter, randomized controlled trial will assess the combined treatment's effectiveness compared to standard thrombolysis alone.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have experienced an acute ischemic stroke and are undergoing intravenous thrombolysis.

Not a fit: Patients with certain pre-existing conditions or those receiving specific medications that may interact adversely will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance recovery and reduce disability in patients with acute ischemic stroke.

How similar studies have performed: Previous studies have suggested neuro-protective effects of levofloxacin in animal models, but this approach in humans is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years.
2. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg)
3. mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15，la (NIHSS) level of consciousness \< 1

Exclusion Criteria:

1. Endovascular treatment
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. Fasting blood glucose lower than 3.9 mmol/L;
7. Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization;
8. Patients allergy to fluoroquinolones or other antibiotics;
9. Patients with a life expectancy less than 3 months or patients unable to complete the study for other reasons;
10. Not willing to be followed up or poor treatment compliance;
11. 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;
12. Other conditions not suitable for enrollment.

Where this trial is running

Changchun, Jilin

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

Study contacts

• Study coordinator: Yi Yang, MD, PhD

Conditions Acute Ischemic Stroke; Acute ischemic stroke; Intravenous thrombolysis; Levofloxacin