A Multi-Center, Randomized, Double-Blind, Parallel Comparative, Phase II Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Versus Moxifloxacin in Treating Adult Patients With Community-Acquired Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 2
- 主要终点
- Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
研究概览
简要总结
The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).
详细描述
Community-acquired Pneumonia (CAP) remains a leading cause of death in both developing and developed countries. In the choice of antibacterial agents used to treat CAP, fluoroquinolones have received considerable attention because of their wide spectrum of bactericidal activity. TG-873870 (Nemonoxacin), a non-fluorinated quinolone (NFQ), is a selective bacterial topoisomerase inhibitor.
This study will Evaluate the clinical efficacy, microbiological efficacy and safety of Intravenous Nemonoxacin compared with Intravenous Moxifloxacin in adult patients with community-acquired pneumonia.
Besides, the pharmacokinetics (PK) of Nemonoxacin in adult patients with CAP after continuous IV Infusion and the pharmacokinetic (PK)/pharmacodynamic (PD)are to be determined.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 75;
- •Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
- •Must have a clinical diagnosis of CAP
- •Chest X-ray and /or CT scan show new or persist/progressive infiltrates
- •Patients with PORT/PSI score II, III or IV.
- •If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
- •The patient is able to receive an intravenous infusion of the drug .
排除标准
- •Patients with PORT/PSI score I or VI.
- •Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
- •Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)
- •Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
- •Potassium is < 3.5 mmol/L
- •Any known disease that seriously affect the immune system
- •Active hepatitis or decompensated cirrhosis;
- •Have used quinolones or fluoroquinolones within 14 days before enrollment
- •Patients who are being or will be on a long-term medication of steroids
研究组 & 干预措施
Nemonoxacin 500 mg
Nemonoxacin 500mg/250mL.
干预措施: Nemonoxacin 500 mg (Drug)
Nemonoxacin 650 mg
Nemonoxacin 650 mg/325mL
干预措施: Nemonoxacin 650 mg (Drug)
Moxifloxacin 400 mg
Moxifloxacin 400mg/250mL
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
时间窗: Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug)
The primary efficacy endpoint of this study was to evaluate whether the clinical cure rate of Nemonoxacin malate sodium chloride is non-inferior to that of Moxifloxacin at visit 4 in the mITT population. At visit 4, the Investigator would assess changes in the symptoms/signs/laboratory tests and chest X-rays/or CT scans associated with this infection, and determined the clinical efficacy in the subjects. The clinical efficacy of the study group and the control group was calculated according to the proportion and percentage of overall clinically cured and clinically ineffective patients in the treatment groups. If the lower limit of the 90% confidence interval for the difference in the clinical cure rate between the study drug and the control drug was larger than -15%, it would be established that the efficacy of Nemonoxacin malate sodium chloride injection was not inferior to that of Moxifloxacin Hydrochloride Sodium Chloride Injection in the treatment of moderate to severe adult CAP.
次要结局
- Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population(Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug))
- Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population(Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug))
- Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population(Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug))
- Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population(Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug))
- Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population(Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug))
- Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population(Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug))
- Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population(Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug))
- Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population(Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug))
- Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population(Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug))
- Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population(Visit 1 (baseline, day -1~1) to Visit 3 (Within 24 hours after stopping the drug))
- Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population(Visit 1 (baseline, day -1~1) to Visit 4 (7-14 days after stopping the drug))