A Multicenter, 2-Cohort Study to Describe the Safety and Efficacy of Ceftaroline Fosamil in Subjects With Staphylococcus Aureus Bacteremia or With Persistent Methicillin-Resistant Staphylococcus Aureus Bacteremia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment
研究概览
简要总结
This is a study of safety and efficacy of ceftaroline fosamil in Subjects with Staphylococcus aureus Bacteremia or with Methicillin-Resistant Staphylococcus aureus (MRSA) Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment.
详细描述
Subjects with either S. aureus bacteremia or persistent MRSA bacteremia will be treated with open label ceftaroline fosamil, safety will be monitored and clearance of bacteremia will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Presence of bacteremia due solely to:
- •S. aureus on at least 1 blood culture within 72 hours of beginning study drug (Cohort A) OR
- •MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment (Cohort B).
- •Male or female ≥ 18 years of age.
- •If female of childbearing potential must be willing to practice sexual abstinence or dual methods of contraception during treatment and for at least 30 days after the last dose of study drug.
- •Expectation of survival for at least 2 months.
排除标准
- •For subjects in Cohort A: previous therapy for more than 48 hours with any parenteral antibiotic with activity against S. aureus within 72 hours of positive blood culture results.
- •For subjects in Cohort B: previous therapy for more than 48 hours with any parenteral antibiotic with activity against MRSA, except vancomycin and/or daptomycin, within 72 hours of positive blood culture results confirming persistence.
- •Previous episode of S. aureus bacteremia within 3 months.
- •Known left-sided endocarditis or prosthetic heart valve.
- •Osteomyelitis or prosthetic joint infection except new onset nonhardware-associated vertebral osteomyelitis.
- •History of any hypersensitivity or allergic reaction to any β-lactam antibacterial agent.
- •Evidence of significant hepatic, hematologic, or immunologic impairment.
- •Pregnant or nursing females.
研究组 & 干预措施
Cohort A
S. aureus on at least 1 blood culture within 72 hours of beginning study drug
干预措施: Ceftaroline fosamil (Drug)
Cohort B
MRSA on a baseline blood culture and on at least 1 additional blood culture after at least 72 hours of vancomycin and/or daptomycin treatment
干预措施: Ceftaroline fosamil (Drug)
结局指标
主要结局
Evaluate the safety of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment
时间窗: 60 days following completion of antibacterial therapy and discharge from the hospital, anticipated between 74 to 119 days
Efficacy outcome measures: * Time to clearance of bacteremia * Time to defervescence * Clinical outcome * Mortality * Readmission
次要结局
- Evaluate the efficacy of ceftaroline fosamil in adult Subjects (≥ 18 years of age) with Staphylococcus aureus Bacteremia or with MRSA Bacteremia persisting after at least 72 hours of vancomycin and/or daptomycin treatment(Between 3 and 119 days)