A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 774
- 试验地点
- 140
- 主要终点
- Number of Participants With Early Clinical Response
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.
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
- Triple (Participant, 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
- •Patients, ages 18 years or older who have signed the informed consent
- •Has qualifying bacterial pneumonia
- •Female patients must not be pregnant at the time of enrollment
- •Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug
排除标准
- •Known or suspected hospital-acquired pneumonia
- •Evidence of significant immunological disease
- •Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
- •Has received an investigational drug within past 30 days
- •Women who are pregnant or nursing
研究组 & 干预措施
Omadacycline
Omadacycline IV; Omadacycline tablets
干预措施: Omadacycline (Drug)
Moxifloxacin
Moxifloxacin IV; Moxifloxacin tablets
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Number of Participants With Early Clinical Response
时间窗: Screening; 72 to 120 hours after the first dose of test article
Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response was determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.
次要结局
- Number of Participants With the Indicated Investigator Assessment of Clinical Response in the ITT Population at the Post Therapy Evaluation (PTE) Visit(Screening; 5 to 10 days after the last day of therapy)
- Number of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CT-PTE) Population(Screening; 5 to 10 days after the last day of therapy)
