A Phase 3b Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Moxifloxacin IV/PO for Treating Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 670
- 试验地点
- 55
- 主要终点
- Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit
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
- •Male or female subjects, age 18 or older who have signed the informed consent form
- •Must have a qualifying community-acquired bacterial pneumonia
- •Subjects must not be pregnant or nursing 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
- •Confirmed or suspected SARS-CoV-2 infection
- •Evidence of significant immunological disease
- •Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
- •Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
- •Has received an investigational drug within the past 30 days
研究组 & 干预措施
Omadacycline
Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.
干预措施: Omadacycline (Drug)
Moxifloxacin
Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Percentage of Participants With Early Clinical Response at the Early Clinical Response (ECR) Visit
时间窗: 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 2CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in CABP symptoms. Response is determined programmatically using 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, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in 2CABP symptoms, worsening of CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event requiring alternative antibacterial treatment, or death
次要结局
- Percentage of Participants With Investigator Assessment of Clinical Response at the Post Therapy Evaluation (PTE) Visit(5 to 10 days after the last dose of test article)
- Percentage of Participants With the Indicated Investigator Assessment of Clinical Response in the Clinically Evaluable-Post Therapy Evaluation (CE-PTE) Population at the PTE Visit(5 to 10 days after the last dose of test article)