A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 655
- 试验地点
- 78
- 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 linezolid in the treatment of adults with acute bacterial skin and skin structure infections.
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 a qualifying skin and skin structure infection
- •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
- •Infections where the outcome is strongly influenced by factors other than protocol-defined treatment and procedures, that require antibacterial treatment for greater than 14 days
- •Evidence of significant immunological disease
- •Severe sepsis or septic shock
- •Has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid
- •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)
Linezolid
Linezolid IV; Linezolid tablets
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of Participants With Early Clinical Response
时间窗: Screening; 48 to 72 hours after the first dose of test article
Early clinical response is defined as clinical success, which is categorized as survival with at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to Screening measurements, without receiving any rescue antibacterial therapy. An indeterminate classification is used for a response 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.
次要结局
- Number of Participants With the Indicated Investigator Assessment of Clinical Response in the mITT Population at the Post Therapy Evaluation (PTE) Visit(Screening; 7 to 14 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 (CE-PTE) Population(Screening; 7 to 14 days after the last day of therapy)
- Number of Participants With the Indicated Type of Adverse Event (AE)(0 to 37 days)