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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741905
• Other study ID #: LVX-IVT
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 13756661217
• Email: doctoryangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of levofloxacin combined with intravenous thrombolysis in treating acute ischemic stroke

Description:

Acute ischemic stroke is a leading cause of disability and mortality. Intravenous thrombolysis is a major therapy for acute ischemic stroke, however, nearly half of patients failed to benefit from it. It is necessary to find new interventions combined to intravenous thrombolysis, which promote the efficacy of intravenous thrombolysis. 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 combined with intravenous thrombolysis in treating acute ischemic stroke patients, the prospective, multicenter and randomized controlled trial was designed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Levofloxacin
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
• Levofloxacin simulant
Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institute of Health stroke scale (NIHSS)	NIHSS ranged from 0 to 42, a low value represents a better outcome	in 24 hours of intravenous thrombolysis
Primary	NIHSS at discharge/7 days	NIHSS ranged from 0 to 42, a low value represents a better outcome	discharge/7 days
Secondary	Hemorrhagic transformation and symptomatic intracranial hemorrhage	defined by computed tomography (CT) brain scan showed bleeding and a concomitant increase in National Institute of Health stroke scale (NIHSS) score of =4 points.	24h,3 days and discharge/7 days
Secondary	Infarct volume after 3 days of Levofloxacin/simulant treatment	assessed by magnetic resonance imaging brain scan	Immediately after 3 days of Levofloxacin/simulant treatment
Secondary	Modified rankin scale (mRS) score at 30 days	mRS ranged from 0 to 6, a low value represents a better outcome	30 days
Secondary	mRS score at 90 days	mRS ranged from 0 to 6, a low value represents a better outcome	90 days