A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 16
- 主要终点
- Sustained clinical cure of CDI at day 26
研究概览
简要总结
The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
详细描述
On Day 1, subjects with diarrhea defined as having three or more unformed bowel movements or >200 mL of unformed stool (for subjects having rectal collection devices) within 24 hours, confirmed by a rapid CDI test (positive for both toxins A & B and glutamate dehydrogenase) to have CDI will be randomized to receive fidaxomicin or vancomycin (1:1 randomization).
Subjects will be treated with study medication from Day 1 to Day 10. Assessment for clinical cure (Test of Cure [TOC]) will take place 48 - 72 hours after End of Treatment (EOT). Subjects not meeting the definition of clinical cure at TOC will be defined as treatment failures.
A stool sample for evaluation of microbial cure will be taken at TOC on Day 12.
Subjects meeting the criteria for clinical cure at TOC will be monitored for recurrence until 28 days after TOC (Day 40).
Treatment of subjects with recurrence of CDI will be at the
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •CDI is confirmed by clinical symptoms and rapid CDI test
- •Subject has not been treated with medication for CDI within the last 10 days
- •Subject is:
- •receiving immunosuppressive therapy (chemotherapy) or is undergoing a stem cell transplant procedure (defined as the time period from the start of conditioning prior to transplant until 6 months after infusion of stem cells) for a hematological malignancy; or
- •receiving immunosuppressive therapy (chemotherapy) for a solid tumor malignancy or following solid organ transplantation; or
- •being treated with immunosuppressive and /or anti-TNF therapy for an auto-immune disease
- •Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study
- •Male and female subjects that are sexually active must agree to practice effective birth control during the study and for 30 days after the end of the study
排除标准
- •The subject has experienced more than one previous episode of CDI within the 3 months prior to study inclusion
- •Taking or requiring to be treated with prohibited medications
- •Unable to take oral study medication
- •Female patients that are pregnant, intend to become pregnant or are breastfeeding
- •History of ulcerative colitis or Crohn's disease
- •History or diagnosis of toxic megacolon or pseudomembranous colitis
- •Hypersensitivity to fidaxomicin or any of its components
- •Hypersensitivity to vancomycin or any of its components
研究组 & 干预措施
Fidaxomicin
Fidaxomicin with alternating matching placebo
干预措施: Fidaxomicin (Drug)
Fidaxomicin
Fidaxomicin with alternating matching placebo
干预措施: Placebo (Drug)
Vancomycin
Participants received 4 doses (1 dose every 6 hours) of oral vancomycin hydrochloride each day for the duration of the 10-day treatment period
干预措施: Vancomycin (Drug)
结局指标
主要结局
Sustained clinical cure of CDI at day 26
时间窗: Day 26
Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either: * ≤3 unformed bowel movements for two consecutive days * ≥50% reduction in the number of unformed bowel movements compared to baseline; or * 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
次要结局
- Clinical Cure of CDI(Day 12)
- Microbial Eradication(Day 12)
- Use of further CDI therapy required(Between Day 10 and Day 12)
- Number of unformed stools(Between Day 10 and Day 12)
- Resolution of diarrhea(Day 12)
- Sustained Clinical Cure of CDI at day 40(Day 40)
- >50% reduction in number of unformed stools compared to baseline(Day 1 to Day 12)
- Recurrence of CDI(Between Day 1 and Day 40)
- Time to recurrence of CDI(Between Day 12 and Day 40)