NCT05799326

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

March 23, 2023

Last Update Submit

October 1, 2024

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic strokeLevofloxacin

Outcome Measures

Primary Outcomes (1)

  • NIHSS at 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 Outcomes (3)

  • Infarct volume after 3 days of Levofloxacin/simulant treatment

    immediately after 3 days of Levofloxacin/simulant treatment

  • Modified rankin scale (mRS) score at 30 days

    30 days

  • mRS score at 90 days

    90 days

Study Arms (2)

Levofloxacin group

EXPERIMENTAL

Levofloxacin 200mg twice per day is administrated.

Drug: Levofloxacin

Levofloxacin simulant group

PLACEBO COMPARATOR

Levofloxacin simulant 200mg twice per day is administrated.

Drug: Levofloxacin simulant

Interventions

LevofloxacinDRUG

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

Levofloxacin group
Levofloxacin simulantDRUG

Levofloxacin simulant is placebo.

Levofloxacin simulant group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Yi Yang, PhD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Yang, PhD

CONTACT

13756661217doctoryangyi@163.com

Zhenni Guo, PhD

CONTACT

18186872986zhen1ni2@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of First Hospital of Jilin University

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 5, 2023

Study Start

June 30, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10

Locations

CN(1)