A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 32
- 主要终点
- Per subject clinical cure rate
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
详细描述
Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and
A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 18~70, BMI ≥ 18 kg/m2
- •Female patients must avoid pregnancy
- •Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
- •Chest X-ray shows inflammatory exudation or infiltration image.
- •Patients who used antibacterial agents (excluding quinolones) within 72 hours before
- •The patient's disease condition permits oral administration
排除标准
- •Patients who have any of bronchiectasis and pulmonary disease.
- •Hospitalized within 14 days before enrollment
- •Have a history of allergy to any quinolone or fluoroquinolone antibiotic
- •Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
- •Renal, liver insufficiency
- •Malabsorption syndrome or other gastrointestinal diseases
- •Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen
- •Steroids longterm use, the dose is at least 20mg of prednisone daily
- •Patients under critical condition.
- •Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
- •Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
- •Patients who received chemotherapy or anti-tumor therapy within 6 months
- •Alcohol abused or drugs banned
- •Patients who used quinolones within two weeks before enrollment
- •Donated more than 500ml of blood within 3 months
- •co-medication of other antibacterial agents required.
- •by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.
研究组 & 干预措施
Nemonoxacin 750 mg
Nemonoxacin 750 mg 2 tablets.
干预措施: Levofloxacin 500 mg placebol (Drug)
Nemonoxacin 500 mg
Nemonoxacin 500 mg 3 tablets
干预措施: Levofloxacin 500 mg placebol (Drug)
Levofloxacin 500 mg
Levofloxacin 500 mg
干预措施: Nemonoxacin 3 tablets (Drug)
结局指标
主要结局
Per subject clinical cure rate
时间窗: 16days
Clinical cure rate equals to number of clinical evaluable divided by number of clinical cured. If subject's clnical outcome is evaluable by principal invastigator, he/she is defined as clinical evaluable.
Per subject microbiological cure rate
时间窗: 16days
Microbiological cure rate equals to number of microbiological evaluable divided by number of eradicated or presumed eradicated.
次要结局
- Pharmacokinetic profile of nemonoxacin in CAP subjects(3days)