NCT01198626终止2 期
A Randomized, Controlled, Double Blind, Multicenter, Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Moxifloxacin for the Treatment of Subjects Requiring Hospitalization for Community-Acquired Bacterial Pneumonia (CABP) With a PORT Score of II or Greater
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Resolution of signs and symptoms of community-acquired bacterial pneumonia
研究概览
简要总结
The purpose of this study is to determine the efficacy, safety and tolerability of JNJ-32729463 compared to moxifloxacin for the treatment of subjects requiring hospitalization for Community-Acquired Bacterial Pneumonia (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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women of childbearing potential must agree to use an acceptable method of birth control
- •clinical diagnosis of community acquired bacterial pneumonia (CABP)
- •PORT score of II or greater
- •able to generate an adequate sputum specimen
- •chest x-ray showing presence of new infiltrates in a lobar or multilobar distribution characteristic of bacterial pneumonia
排除标准
- •history of tendon damage/disorders due to quinolone therapy
- •uncorrected hypokalemia
- •history of myasthenia gravis
- •intubated at the time of consent OR subject is a candidate for enrollment into the open-label S. aureus arm and has been intubated greater than 12 hours prior to randomization
- •mild CABP with a PORT score of less than II
- •viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis
- •pneumonia suspected to be secondary to aspiration
- •primary, solitary lung abscess
- •healthcare-associated pneumonia, hospital-acquired pneumonia, or ventilator-associated pneumonia
- •known bronchial obstruction or a history of postobstructive pneumonia.
- •primary lung cancer or another malignancy metastatic to the lungs
- •cystic fibrosis, known or suspected Pneumocystis jiroveci (carinii) pneumonia, or known or suspected active tuberculosis
- •infection that necessitates the use of a concomitant antibacterial agent in addition to study medication
- •systemic antibiotics within the last 96 hours before randomization, with exceptions
- •hospitalized for greater than 72 hours for any reason 30 days before randomization (excluding the 24 hour period before enrollment).
- •history of a serious hypersensitivity reaction to any quinolone including moxifloxacin.
- •female and pregnant, breastfeeding, or may be pregnant.
- •Other protocol-specific eligibility criteria may apply
研究组 & 干预措施
JNJ-32729463
Experimental
干预措施: JNJ-32729463 (Drug)
moxifloxacin
Active Comparator
干预措施: moxifloxacin (Drug)
JNJ-32729463 Open-Label
Experimental
subjects with suspected or confirmed S. aureus CABP may be entered into an open-label JNJ 32729463 treatment group at selected study sites
干预措施: JNJ-32729463 (Open-Label) (Drug)
结局指标
主要结局
Resolution of signs and symptoms of community-acquired bacterial pneumonia
时间窗: Day 19 (Test of Cure Visit)
次要结局
- Daily signs and symptoms of CABP(Up to Day 19)
- Microbiological response: per-pathogen and per-subject(Day 19 (Test of Cure Visit))
- Percent of subjects with resolution of signs and symptoms of CABP(Day 3 and Day 4)
- Clinical outcome in subjects with S. pneumoniae(Day 19 (Test of Cure Visit))
- Rate of superinfections or new infections(Day 30)
- Time to oral switch(Day 14)
- All-cause mortality(Up to Day 30)
研究者
研究点 (1)
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