A Phase II, Randomized, Double-Blind, Multicenter, Comparative Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 231
- 试验地点
- 6
- 主要终点
- Clinical Response in the ITT Population
研究概览
简要总结
Study to Determine the Safety, Tolerability, Pharmacokinetics and Efficacy of Oral Nafithromycin Versus Oral Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia (CABP) in Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the clinical criteria for CABP based on following:
- •Clinical symptoms (new or worsening)
- •Vital sign abnormalities
- •Laboratory abnormalities
- •Radiographic evidence of CABP
排除标准
- •Subjects with any of the following confirmed or suspected types of pneumonia:
- •Aspiration pneumonia
- •Hospital-acquired bacterial pneumonia (HABP)
- •Healthcare-associated bacterial pneumonia (HCAP)
- •Ventilator-associated bacterial pneumonia (VABP)
- •Pneumonia that may be caused by pathogen(s) resistant to either study drug
- •Receipt of 1 or more dose(s) of a potentially effective systemic antibacterial treatment for treatment of the current CABP
- •Suspected or confirmed non-infectious causes of pulmonary infiltrates
- •Subjects requiring concomitant adjunctive or additional potentially-effective systemic antibacterial treatment for management of CABP
研究组 & 干预措施
Nafithromycin 800 mg 3 days
PO q24h for 3 days; subjects will receive matching placebo , to maintain the blind
干预措施: Nafithromycin 800 mg 3 days (Drug)
Nafithromycin 800 mg 5 days
PO q24h for 5 days; subjects will receive matching placebo, to maintain the blind
干预措施: Nafithromycin 800 mg 5 days (Drug)
Moxifloxacin 400 mg
PO q24h for 7 days;subjects will also receive two nafithromycin placebo tablets PO q24h on Days 1 through Day 7 to maintain the blind
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
Clinical Response in the ITT Population
时间窗: Day 4 from start of drug administration
The primary efficacy endpoint was clinical response (response, non-response, or indeterminate) at Day 4, tested in the ITT population. Clinical response was determined programmatically using the investigator's assessment of CABP symptoms entered into the eCRF. The severity of the subject CABP symptoms of dyspnea (shortness of breath), cough, production of purulent sputum, and pleuritic chest pain were evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Symptom Severity Guidance
次要结局
- Clinical Response in the Micro-ITT Population(Day 4 from start of drug administration)