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Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis 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, Intravenous thrombolysis, Levofloxacin

Eligibility Criteria

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

Inclusion Criteria: Age 18-75 years. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg) mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15,la (NIHSS) level of consciousness < 1 Exclusion Criteria: Endovascular treatment 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; Fasting blood glucose lower than 3.9 mmol/L; Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization; 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

National Institute of Health stroke scale (NIHSS)
NIHSS ranged from 0 to 42, a low value represents a better outcome
NIHSS at discharge/7 days
NIHSS ranged from 0 to 42, a low value represents a better outcome

Secondary Outcome Measures

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

Full Information

First Posted
February 6, 2023
Last Updated
September 18, 2023
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT05741905
Brief Title
Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Official Title
Safety and Efficacy of Levofloxacin Combined With Intravenous Thrombolysis for Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
June 1, 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
Data Monitoring Committee
Yes

5. Study Description

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

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, Intravenous thrombolysis, 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
Other Intervention Name(s)
Intravenous Thrombolysis
Intervention Description
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin simulant
Other Intervention Name(s)
Intravenous Thrombolysis
Intervention Description
Levofloxacin simulant is placebo. Intravenous thrombolysis is one of the treatments for acute ischemic stroke.
Primary Outcome Measure Information:
Title
National Institute of Health stroke scale (NIHSS)
Description
NIHSS ranged from 0 to 42, a low value represents a better outcome
Time Frame
in 24 hours of intravenous thrombolysis
Title
NIHSS at discharge/7 days
Description
NIHSS ranged from 0 to 42, a low value represents a better outcome
Time Frame
discharge/7 days
Secondary Outcome Measure Information:
Title
Hemorrhagic transformation and symptomatic intracranial hemorrhage
Description
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.
Time Frame
24h,3 days and discharge/7 days
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
mRS ranged from 0 to 6, a low value represents a better outcome
Time Frame
30 days
Title
mRS score at 90 days
Description
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. Acute ischemic stroke patients underwent intravenous thrombolysis, treated with ateplase (0.9mg/kg) mRS≤1 before stroke onset, NIHSS ≥ 5 and ≤ 15,la (NIHSS) level of consciousness < 1 Exclusion Criteria: Endovascular treatment 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; Fasting blood glucose lower than 3.9 mmol/L; Patients with symptomatic intracranial hemorrhage confirmed by clinical signs and imaging before randomization; 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, MD, PhD
Phone
13756661217
Ext
0086
Email
doctoryangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen-Ni Guo, MD, PhD
Phone
18186872986
Ext
0086
Email
zhen1ni2@163.com
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 Combined With Intravenous Thrombolysis for Acute Ischemic Stroke

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