A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 632
- 主要终点
- Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
研究概览
简要总结
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
详细描述
Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent.
- •Male or female ≥ 18 years of age. Females of childbearing potential must agree to use an adequate and reliable method of contraception.
- •Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within 72 hours prior to randomization.
排除标准
- •More than one previous episode of CDAD in the 3-month period prior to randomization.
- •Evidence of life-threatening or fulminant CDAD.
- •Likelihood of death within 72 hours from any cause.
- •History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
- •Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF)
- •Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones.
- •Unable or unwilling to comply with all protocol requirements.
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
研究组 & 干预措施
Cadazolid
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
干预措施: Vancomycin-matching placebo (Drug)
Cadazolid
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
干预措施: Cadazolid (Drug)
Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
干预措施: Vancomycin (Drug)
Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
干预措施: Cadazolid-matching placebo (Drug)
结局指标
主要结局
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
时间窗: Up to Day 12 on average (end-of-treatment + 2 days)
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.
Clinical Cure Rate (CCR) in the Per-protocol Population
时间窗: Up to Day 12 on average (end-of-treatment + 2 days)
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.
次要结局
- Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population(Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days))
- Kaplan-Meier Estimates for Resolution of Diarrhea(Up to Day 10)
- Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores(Day 1 (baseline) and Day 3)