A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 860
- 主要终点
- Early clinical response rate in the Intent to Treat (ITT) population
研究概览
简要总结
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
详细描述
Community-acquired bacterial pneumonia (CABP) 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 against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ≥ 18 years of age
- •An acute onset of at least 3 of the following signs and symptoms (new or worsening):
- •Production of purulent sputum
- •Shortness of breath (dyspnea)
- •Chest pain due to pneumonia
- •At least 1 of the following:
- •Hypothermia
- •Presence of pulmonary rales and/or evidence of pulmonary consolidation
- •PORT Risk Class II, III, or IV
- •Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study
- •Not received any systemic antibiotics during the prior 7 days
排除标准
- •Ventilator-associated pneumonia
- •Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease
- •Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms
- •Presence of known:
- •Viral or fungal pneumonia
- •Pneumocystis jiroveci pneumonia
- •Aspiration pneumonia
- •Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure)
- •Primary or metastatic lung cancer
- •Cystic fibrosis
- •Active or suspected tuberculosis
- •Known HIV or myasthesia gravis
研究组 & 干预措施
Solithromycin
Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7
干预措施: Solithromycin (Drug)
Solithromycin
Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7
干预措施: Placebo to match solithromycin (Other)
Moxifloxacin
Moxifloxacin 400 mg PO daily on Day 1 through Day 7
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Early clinical response rate in the Intent to Treat (ITT) population
时间窗: 72 [±12] hours after the first dose of study drug
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production.
次要结局
- Clinical success rates in the ITT and Clincally Evaluable (CE) populations(5 to 10 days after the last dose of study drug)
- Early clinical response rate in the microITT population(72 [±12] hours after the first dose of study drug)