EUCTR2013-004619-31-DK进行中（未招募）1 期
A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clostridium difficile Infection in an older population - EXTEND
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 364
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject is 60 years of age or over.
- •CDI is confirmed by clinical symptoms in the 24 hours prior to randomization and CDI test confirmed positive for presence of C. difficile toxin A or B in stool within 48 hr prior to randomization.
- •Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •Subject agrees not to participate in another interventional study whilst participating in this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Subject is taking or requiring to be treated with prohibited medications
- •Subject has received more than one day of dosing of any therapy for CDI within the last 48 hours
- •Subject has experienced more than 2 previous episodes of CDI in the 3 months prior to study enrolment
- •Subject is unable to swallow oral study medication.
- •Subject has a current diagnosis of toxic megacolon.
- •Subject is not willing to adhere to the provisions of treatment and observation specified in the protocol.
- •Subject has been randomized into this study previously, has taken any investigational drug within 28 days or 5 half lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
- •Subject has previously participated in a CDI vaccine study
- •Subject has hypersensitivity to fidaxomicin, vancomycin or any of its components.
- •Any clinical condition which, in the opinion of the Investigator, would not allow safe completion of this study.
研究者
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