A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 608
- 主要终点
- Percentage of Participants Experiencing an Adverse Event (AE)
研究概览
简要总结
A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is able to read and sign a consent form;
- •Is from ≥18 to <90 years of age;
- •Has diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
- •Tests positive for Clostridium difficile;
- •If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.
排除标准
- •Has toxic megacolon and/or known small bowel ileus;
- •Has received treatment with intravenous immune globulin (IVIG) within the past 30 days;
- •Has received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
- •Has received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
- •Has received an investigational vaccine against Clostridium difficile;
- •Has received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
- •Has more than 2 episodes of CDAD within 90 days;
- •Has had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy);
- •Has a history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
- •Is unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
- •Is unable to discontinue opiate treatment unless on a stable dose;
- •Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
- •Has had stool studies positive for pathogenic ova and/or parasites;
- •Has an intolerance or hypersensitivity to daptomycin and/or vancomycin;
- •Has a life-threatening illness at the time of enrollment;
- •Has poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
- •Has received an investigational drug or participated in any experimental procedure within 1 month;
- •Has human immunodeficiency virus (HIV), a cluster of differentiation (CD) 4 count <200 cells/mm^3 within 6 months of start of study therapy;
- •Anticipates that certain antibacterial therapy for a non-CDAD infection will be required for >7 days;
- •Is unable to discontinue Saccharomyces or similar probiotic;
- •Is on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
- •Is unable to comply with the protocol requirements;
- •Has any condition that, in the opinion of the Investigator, might interfere;
- •Is not expected to live for less than 8 weeks.
研究组 & 干预措施
CB-183,315
Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days.
干预措施: CB-183,315 (Drug)
CB-183,315
Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days.
干预措施: Placebo (Drug)
Vancomycin
Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Percentage of Participants Experiencing an Adverse Event (AE)
时间窗: Up to 30 days after EOT (up to Day 40)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
Percentage of Participants Discontinuing From Study Treatment Due to an AE
时间窗: Up to EOT (up to Day 10)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment.
Adjusted Percentage of Participants Meeting Clinical Response Criteria for Cure at End of Treatment (EOT)
时间窗: Up to 3 days after EOT (up to Day 13)
The percentage of participants considered "cured" (i.e., ≤2 loose stools per 24 hour period for at least 2 consecutive days and no need for additional antibiotics during the 3 days following EOT) was determined in the mMITT population. A CDAD diagnosis was defined as: 1) diarrhea with a minimum of 3 unformed bowel movements (UBM) or \>200 mL volume of stool for participants with a collection device (e.g., rectal tube or colostomy bag) over 24 hours; and 2) a positive result for Clostridium difficile toxin by enzyme immunoassay (EIA), polymerase chain reaction (PCR), or a cell culture cytotoxin neutralization assay. Percentages were first stratified according to age (\<75 or ≥75 years) and number of previous CDAD episodes (0 or ≥1) and constructed using Mehrotra-Railkar continuity-corrected minimum-risk stratum weights, and the weighted averages were then derived across strata in order to calculate the adjusted percentage.
次要结局
- Adjusted Percentage of Participants With Sustained Clinical Response at End of Study(Up to 40 days after EOT (up to Day 50))
- Number of Clinical Failure Events up to Day 40(Up to 30 days after EOT (up to Day 40))