Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

September 13, 2023 updated by: Yi Yang

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NIHSS at discharge/7 days
Time Frame: discharge/7 days
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
discharge/7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Yang

Investigators

  • Principal Investigator: Yi Yang, PhD, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

March 23, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVX-AIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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