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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 109
- 主要终点
- Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
研究概览
简要总结
The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CDI is confirmed by clinical symptoms (either > 3 unformed bowel movements or ≥ 200ml of unformed stool (for subjects having rectal collection devices)) 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.
- •Subject agrees not to participate in another interventional study whilst participating in this study.
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.
研究组 & 干预措施
Fidaxomicin Extended Pulsed Regimen (EPFX)
Participants receive 200 mg fidaxomicin from day 1 to day 5 twice daily, followed by a 1-day gap (day 6) before starting alternate day dosing of 1 tablet of fidaxomicin 200 mg once daily from day 7 to day 25.
干预措施: Fidaxomicin (Drug)
Vancomycin
Participants receive 125 mg vancomycin from day 1 to day 10, 4 times daily.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Percentage of Participants with a Sustained Clinical Cure of CDI at 30 Days after End of Treatment
时间窗: Day 40 (for vancomycin) and day 55 (for fidaxomicin extended pulsed regimen [EPFX])
Sustained clinical cure is defined as an assessment of clinical response at test of cure (TOC; day 12 for vancomycin and day 27 or 12 for EPFX arm) and no recurrence of CDI from TOC until time of assessment. Clinical response is determined by the investigator based on the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) criteria at TOC. Treatment response is present when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improves and no new signs of severe disease develops.
次要结局
- Disease-free Survival After Day 10(From day 10 up to day 90)
- Percentage of Participants with a Clinical Response of CDI at Day 12(Day 12)
- Percentage of Participants with a Recurrence of CDI at Day 40, Day 55 and Day 90(Day 40, 55, 90)
- Time to Recurrence of CDI after End of Active Treatment(From day 10 up to day 90)
- Number of Participants with a Relapse on Day 90 as Determined by Whole Genome Sequencing of C. Difficile Isolates(Baseline through day 90)
- Percentage of Participants with a Sustained Clinical Cure of CDI at Day 40, Day 55 and Day 90(Day 40, 55, 90)
- Percentage of Participants with a Clinical Response of CDI at 2 Days after End of Treatment(Day 12, 27)
- Time to Resolution of Diarrhea (TTROD)(Up to day 10 (for vancomycin) or up to day 25 (for EPFX))