Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

NCT ID: NCT05799326

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levofloxacin group

Levofloxacin 200mg twice per day is administrated.

Group Type EXPERIMENTAL

Levofloxacin

Intervention Type DRUG

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

Levofloxacin simulant group

Levofloxacin simulant 200mg twice per day is administrated.

Group Type PLACEBO_COMPARATOR

Levofloxacin simulant

Intervention Type DRUG

Levofloxacin simulant is placebo.

Interventions

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Levofloxacin

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

Intervention Type DRUG

Levofloxacin simulant

Levofloxacin simulant is placebo.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yi Yang

OTHER

Sponsor Role lead

Responsible Party

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Yi Yang

Associated Dean of First Hospital of Jilin University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yi Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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First Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Yang, PhD

Role: CONTACT

13756661217 ext. 0086

Zhenni Guo, PhD

Role: CONTACT

18186872986 ext. 0086

Facility Contacts

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Yi Yang, MD, PhD

Role: primary

+86-18186870008

Other Identifiers

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LVX-AIS

Identifier Type: -

Identifier Source: org_study_id

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