A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral CEM-101 Compared to Oral Levofloxacin in the Treatment of Patients With Community-Acquired Bacterial Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 主要终点
- Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit
研究概览
简要总结
Study to evaluate the safety and efficacy of oral CEM-101 compared to oral Levofloxacin in the treatment of adults with moderate to moderately severe community-acquired bacterial pneumonia.
详细描述
Community-acquired bacterial pneumonia is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity again CABP pathogens. CEM-101 is the first fluoroketolide with excellent in vitro and in vivo activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of community acquired bacterial pneumonia (e.g. cough with purulent sputum or change in character of sputum consistent with bacterial infection, dyspnea or tachypnea, chest pain due to pneumonia, fever, presence of rales and/or signs of consolidation).
- •No prior systemic antibacterial therapy, unless failed other therapy.
- •Chest Xray shows new lobar or multilobar infiltrate(s) consistent with acute bacterial pneumonia.
- •PORT Risk Class II, III, or IV <=105
- •Ability to take oral medication.
排除标准
- •Severe chronic obstructive pulmonary disease FEV1 <30%.
- •Hospitalization within 90 days or residence in a long-term-care facility within 30 days prior to the onset of symptoms
- •Chemotherapy or radiation therapy within the previous 3 months.
- •Significant hepatic, hematological, renal abnormalities.
- •Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g. life expectancy <30 days).
研究组 & 干预措施
Levofloxacin
干预措施: Levofloxacin (Drug)
CEM-101
干预措施: CEM-101 (Drug)
结局指标
主要结局
Clinical Success in the Intent to Treat (ITT) population at the Treatment of Cure (TOC) visit
时间窗: 5 to 10 days after the last dose of study drug
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
Clinical Success in the Clinically Evaluable (CE) population at the Treatment of Cure (TOC) Visit
时间窗: 5 to 10 days after the last dose of study drug
Clinical Success defined as continued improvement or complete resolution of baseline signs and symptoms and if available, an improved/stable chest radiograph after the end of treatment
次要结局
- By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the Treatment of Cure (TOC) visit(5 to 10 days after the last dose of study drug)
- By Patient Microbiological Response in the Microbiological Intent to Treat (microlITT) population at the end of treatment (EOT)(5 days of study drug treatment)
- By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at the end of treatment (EOT)(5 days of study drug treatment)
- By-patient Microbiological Response in the Microbiologically Evaluable (ME) populations at Treatment of Cure (TOC) visit(5 to 10 days after the last dose of study drug)
- Clinical Response in the Intent to Treat (ITT) population at End of Treatment (EOT)(5 days of study drug treatment)
- Clinical Response in the microbiological intent to treat (microlITT) population at the end of treatment (EOT)(5 days of study drug treatment)
- Clinical Response in the clinically evaluable (CE) population at the end of treatment (EOT)(5 days of study drug treatment)
- Clinical REsponse in the Microbiologically Evaluable (ME) population at the end of treatment (EOT)(5 days of study drug treatment)
- Early Clinical Response in the intent to treat (ITT) population at Day 3(3 days of study drug treatment)
- Percentage of patients at each visit who have resolution of all baseline signs and symptoms in the clinically evaluable (CE) population(Day 3, Day 5 (end of treatment), and 5 to 10 days after the last dose of study drug (test of cure visit))
- Percentage of patients at Day 3 who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production(3 days of study drug treatment)
- Percentage of patients at the end of treatment (EOT) who have resolution of cough, dyspnea, chest pain due to pneumonia and sputum production(5 days of study drug treatment)
- Percentage of patients at Day 3 who are clinically stable(3 days of study drug treatment)
- Percentage of patients at the end of treatment (EOT) who are clinically stable(5 days of study drug treatment)