A Phase III Randomized, Open-labeled Clinical Trial of MK-3009 (Daptomycin) in Patients With Skin and Soft Tissue Infections, Septicemia and Right-sided Infective Endocarditis Caused by MRSA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 主要终点
- Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
研究概览
简要总结
The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).
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
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both Sexes, Aged 20 Years Or Older
- •Japanese Participants With Skin And Soft Tissue Infections, Septicemia, or RIE Known Or Suspected To Be Caused By MRSA
- •Written Informed Consent
排除标准
- •Participants With Skin and Soft Tissue infections That Can Be Treated By Surgery Alone
- •Participants With Pneumonia
研究组 & 干预措施
MK-3009 (daptomycin) 4 mg/kg
干预措施: Daptomycin 4 mg/kg (Drug)
MK-3009 (daptomycin) 6 mg/kg
干预措施: Daptomycin 6 mg/kg (Drug)
结局指标
主要结局
Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC)
时间窗: 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE)
Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT). MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline.
Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC
时间窗: 7-14 days for SSTI, 14-42 days for septicemia and RIE
Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen.
次要结局
- EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT).(7-14 days for SSTI, 14-42 days for septicemia and RIE)
- Study Investigators' Assessment of Clinical Response at TOC(7-14 days for SSTI, 14-42 days for septicemia and RIE)
- EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT).(7-14 days for SSTI, 14-42 days for septicemia and RIE)
- Study Investigators' Assessment of Clinical Response at EOT(7-14 days for SSTI, 14-42 days for septicemia and RIE)
