NCT01691248已完成3 期
DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)0 个研究点目标入组 611 人开始时间: 2012年10月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 611
- 主要终点
- Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.
研究概览
简要总结
The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Male or female 18 years of age or older.
- •Females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment.
- •Is undergoing HSCT with planned Fluoroquinolone prophylaxis.
- •Informed consent is provided.
排除标准
- •Ongoing active CDAD infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin A and/or B [or their respective genes, tcdA and/or tcdB] of C. difficile in the stool) or current treatment for CDAD.
- •Undergoing cord blood transplants.
- •Has fulminant colitis, toxic megacolon, or ileus.
- •A history of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- •Women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug).
- •Use of any drugs potentially useful in the treatment of CDAD (e.g. oral Vancomycin, Metronidazole, oral Bacitracin, Fusidic Acid, Rifaximin, and Nitazoxanide).
- •Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.
- •Participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo tablet once daily for no longer than 40 days
干预措施: Placebo (Drug)
Fidaxomicin
Active Comparator
200 mg Fidaxomicin tablet once daily for no longer than 40 days
干预措施: fidaxomicin (Drug)
结局指标
主要结局
Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 30 Days Post-treatment Follow-up.
时间窗: Up to 30 days post-treatment
CDAD is defined as follows: Diarrhea: (change in bowel habits with \>3 unformed bowel movements in a 24 hour period) and the presence of either toxin A and/or B (or their respective genes, tcdA and/or tcdB) of C. difficile in the stool determined by C. difficile toxin assay. Wald 95% Confidence Intervals (CI) are presented.
次要结局
- Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to Day 70 of Study.(Up to Day 70 of study)
- Percentage of Participants With Occurrence of CDAD From Start of Study Treatment up to 60 Days Post-treatment.(Up to 60 days post-treatment)
研究者
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