Acute Ischemic StrokeNCT05799326
Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke
A study testing Levofloxacin and Levofloxacin simulant in people with Acute Ischemic Stroke, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of levofloxacin in treating acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Levofloxacin and Levofloxacin simulant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, +86-18186870008, doctoryangyi@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Levofloxacin, Levofloxacin simulant
- Keywords
- Acute ischemic stroke, Levofloxacin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Levofloxacin is a quinolone antibiotics and newly identified neuro-protective agent.
Levofloxacin simulantDrug
Levofloxacin simulant is placebo.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin group | Experimental | Levofloxacin 200mg twice per day is administrated. Receives: Drug: Levofloxacin |
| Levofloxacin simulant group | Placebo comparator | Levofloxacin simulant 200mg twice per day is administrated. Receives: Drug: Levofloxacin simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS at discharge/7 days
National Institute of Health stroke scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.
Measured: discharge/7 days
Secondary outcomes (3)
Infarct volume after 3 days of Levofloxacin/simulant treatment
assessed by magnetic resonance imaging brain scan
Measured: immediately after 3 days of Levofloxacin/simulant treatment
Modified rankin scale (mRS) score at 30 days
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
Measured: 30 days
mRS score at 90 days
Modified Rankin Scale (mRS), ranged from 0 to 6, a low value represents a better outcome.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start30 Jun 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
- Investigators
- Yi Yang, PhD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799326
- Sponsor's protocol ID
- LVX-AIS
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Levofloxacin for Acute Ischemic Stroke: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05799326
- Acronym / sponsor ID
- LVX-AIS
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Levofloxacin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin group | Experimental | Drug: LevofloxacinLevofloxacin 200mg twice per day is administrated. |
| Levofloxacin simulant group | Placebo comparator | Drug: Levofloxacin simulantLevofloxacin simulant 200mg twice per day is administrated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevofloxacinLevofloxacin is a quinolone antibiotics and newly identified neuro-protective agent. | Drug | Levofloxacin group |
| Levofloxacin simulantLevofloxacin simulant is placebo. | Drug | Levofloxacin simulant group |
Primary outcome
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.
3 secondary outcomes
Infarct volume after 3 days of Levofloxacin/simulant treatment
Time frame: immediately after 3 days of Levofloxacin/simulant treatment
Modified rankin scale (mRS) score at 30 days
Time frame: 30 days
mRS score at 90 days
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Yang, PhD principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levofloxacin and Levofloxacin simulant in people with Acute Ischemic Stroke, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, PhD (13756661217 ext. 0086, doctoryangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS at discharge/7 days (time frame: discharge/7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.