NCT00384527终止3 期
Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Clinical response (resolution of all symptoms of CDAD)
研究概览
简要总结
The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
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
- •Age ≥ 18 years.
- •Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of CDAD:
- •abdominal pain or cramps
- •peripheral leukocytosis
- •C. difficile toxin A or B detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay.
- •Patients willing to avoid the following medications during the study:
- •oral and intravenous metronidazole
- •oral vancomycin
- •anti-peristaltic drugs
- •opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study)
- •Saccharomyces cerevisiae (baker's yeast)
- •Lactobacillus GG
- •cholestyramine
- •colestipol
排除标准
- •Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy).
- •Patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of CDAD.
- •Patients with severe lactose intolerance.
- •Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment.
- •Patients unable to take oral medications.
- •Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. [Patients that have taken up to 3 doses of metronidazole or vancomycin can be included in the study].
- •Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
- •Patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness.
- •History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations.
研究组 & 干预措施
1
Experimental
干预措施: Nitazoxanide (Drug)
2
Active Comparator
干预措施: Vancomycin (Drug)
结局指标
主要结局
Clinical response (resolution of all symptoms of CDAD)
时间窗: End of treatment (day 12-14 after beginning treatment)
次要结局
- Clinical Recurrence(Clinical response at the end of treatment with recurrent symptoms of CDAD prior to study day 31, but no C. difficile toxins detected.)
- Time from first dose to resolution of symptoms of CDAD(Any time after beginning treatment and must be sustained through end of treatment visit)
- Microbiological Recurrence(Clinical response at end of treatment visit with recurrence of symtpoms prior to study day 31 and C. difficile toxins detected in stool.)
- Sustained clinical response(End of treatment response sustained through study day 31.)
研究者
研究点 (10)
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