NCT01756924终止2 期
Safety and Efficacy of CEM-102 With Rifampin Compared to Standard Therapy in Patients With Prosthetic Joint Infections or Spacer Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Arrevus Inc.
- 入组人数
- 14
- 主要终点
- Bacterial eradication of joint infection
研究概览
简要总结
To determine if oral antibiotic treatment with CEM-102 and Rifampin is as effective and safe as the standard of care antibiotic therapy for the treatment of hip and knee prosthetic joint or spacer 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
- 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
- •Prosthetic knee or hip joint infection
- •Infected joint spacer
- •Able to swallow tablets
- •Able to voluntarily sign the informed consent form
- •Females of childbearing potential must use an acceptable method of birth control
- •The joint infection must be attributed to bacterial pathogens sensitive to fusidic acid and rifampin
排除标准
- •History of hypersensitivity or intolerability to sodium fusidate (Fucidin®), or to rifampin
- •Females who are pregnant or lactating
- •Requirement for significant immunosuppression
- •Bacteremia
- •Known cirrhosis or decompensated liver disease
- •Current treatment for HIV or Hepatitis C
- •Seizure disorder, requiring anti-convulsants
研究组 & 干预措施
CEM-102 plus Rifampin
Experimental
干预措施: CEM-102 (Drug)
CEM-102 plus Rifampin
Experimental
干预措施: Rifampin (Drug)
Standard of Care
Active Comparator
干预措施: IV or Oral standard of care antibiotics (Drug)
结局指标
主要结局
Bacterial eradication of joint infection
时间窗: 3 to 6 months
Clinical success is defined as the absence of persistent infection in a patient who did not receive alternative antibiotic therapy targeting the infection.
次要结局
未报告次要终点
研究者
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