Health TrialsbyHealthPanel

Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYi Yang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levofloxacin

    Drug

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

  • Levofloxacin simulant

    Drug

    Levofloxacin simulant is placebo.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Levofloxacin groupExperimental treatment 1 intervention
Group B: Levofloxacin simulant groupPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
discharge/7 days

Secondary outcomes

1

Infarct volume after 3 days of Levofloxacin/simulant treatment

assessed by magnetic resonance imaging brain scan

Time frame
immediately after 3 days of Levofloxacin/simulant treatment
2

Modified rankin scale (mRS) score at 30 days

Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

Time frame
30 days
3

mRS score at 90 days

Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov
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