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Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Levofloxacin
Levofloxacin simulant
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute ischemic stroke, Levofloxacin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 years. 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. mRS≤1 before stroke onset. Signed and dated informed consent is obtained. Exclusion Criteria: Patients with transient ischemic attack and those 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. Concurrent infection. 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.

Sites / Locations

  • First Hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levofloxacin group

Levofloxacin simulant group

Arm Description

Levofloxacin 200mg twice per day is administrated.

Levofloxacin simulant 200mg twice per day is administrated.

Outcomes

Primary Outcome Measures

NIHSS at 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
assessed by magnetic resonance imaging brain scan
Modified rankin scale (mRS) score at 30 days
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
mRS score at 90 days
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

Full Information

First Posted
March 23, 2023
Last Updated
September 13, 2023
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT05799326
Brief Title
Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke
Official Title
Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute ischemic stroke, Levofloxacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin group
Arm Type
Experimental
Arm Description
Levofloxacin 200mg twice per day is administrated.
Arm Title
Levofloxacin simulant group
Arm Type
Placebo Comparator
Arm Description
Levofloxacin simulant 200mg twice per day is administrated.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin simulant
Intervention Description
Levofloxacin simulant is placebo.
Primary Outcome Measure Information:
Title
NIHSS at discharge/7 days
Description
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
Time Frame
discharge/7 days
Secondary Outcome Measure Information:
Title
Infarct volume after 3 days of Levofloxacin/simulant treatment
Description
assessed by magnetic resonance imaging brain scan
Time Frame
immediately after 3 days of Levofloxacin/simulant treatment
Title
Modified rankin scale (mRS) score at 30 days
Description
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
Time Frame
30 days
Title
mRS score at 90 days
Description
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years. 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. mRS≤1 before stroke onset. Signed and dated informed consent is obtained. Exclusion Criteria: Patients with transient ischemic attack and those 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. Concurrent infection. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, PhD
Phone
13756661217
Ext
0086
Email
doctoryangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenni Guo, PhD
Phone
18186872986
Ext
0086
Email
zhen1ni2@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Yang, PhD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Yang, MD, PhD
Phone
+86-18186870008
Email
doctoryangyi@163.com

12. IPD Sharing Statement

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Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

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