Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

Sponsor

Yi Yang (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05799326

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: Levofloxacin Drug: Levofloxacin simulant	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Levofloxacin group Levofloxacin 200mg twice per day is administrated.	Drug: Levofloxacin Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.
Placebo Comparator: Levofloxacin simulant group Levofloxacin simulant 200mg twice per day is administrated.	Drug: Levofloxacin simulant Levofloxacin simulant is placebo.

Arm

Intervention/Treatment

Experimental: Levofloxacin group

Levofloxacin 200mg twice per day is administrated.

Drug: Levofloxacin

Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.

Placebo Comparator: Levofloxacin simulant group

Levofloxacin simulant 200mg twice per day is administrated.

Drug: Levofloxacin simulant

Levofloxacin simulant is placebo.

Outcome Measures

Primary Outcome Measures

National Institute of Health stroke scale (NIHSS) after 3 days of Levofloxacin/simulant treatment [immediately after 3 days of Levofloxacin/simulant treatment]
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
NIHSS at discharge/7 days [discharge/7 days]
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

Secondary Outcome Measures

Infarct volume after 3 days of Levofloxacin/simulant treatment [immediately after 3 days of Levofloxacin/simulant treatment]
assessed by magnetic resonance imaging brain scan
Modified rankin scale (mRS) score at 30 days [30 days]
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
mRS score at 90 days [90 days]
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65 years.
The patients were clinically diagnosed with acute ischemic stroke with NIHSS score ≥6 points and ≤25 points.
mRS≤2 before stroke onset.
Signed and dated informed consent is obtained.
Levofloxacin/simulant treatment initiated with in 24h of acute ischemic stroke.

Exclusion Criteria:

Patients 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.
Ion disorders: hyponatremia (Na<130mmol/L), hypokalemia (K<3.5mmol/L), hyperkalemia (K>5.5mmol/L).
Fasting 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.