NCT06600711尚未招募3 期
Randomized Control Trial of Nitazoxanide for the Treatment of Cryptosporidium Infection in Malnourished Children in Bangladesh
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 480
- 主要终点
- Days of Cryptosporidium-associated diarrhea
研究概览
简要总结
The goal of this clinical trial is to learn if nitazoxanide (NTZ) can treat Cryptosporidium infection in children age 6-12 months. The main questions it aims to answer are:
- Does NTZ treatment of diarrheal Cryptosporidium infection lower the number of days of diarrhea?
- Does NTZ treatment of diarrheal and non-diarrheal Cryptosporidium infection lower the number of days that parasites can be found in the stool?
Researchers will compare NTZ to a placebo (a look-alike substance that contains no drug) to see if NTZ works to treat Cryptosporidium.
Participants will:
- Take NTZ or placebo for 3 days
- Receive regular visits from field research assistants
- Provide blood and urine samples
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
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tests positive for Cryptosporidium by stool point-of-care test, with or without active diarrhea
- •family plans on remaining in the area for next 6 months
排除标准
- •history of hypersensitivity to nitazoxanide.
- •taking warfarin. Tizoxanide, the metabolite of nitazoxanide is highly bound to plasma proteins and may compete with binding sites of other highly plasma bound drugs with narrow therapeutic indices, including warfarin.
- •history of renal insufficiency or a baseline serum creatinine = 40 µmol/L. Renal clearance of the drug has not been studied.
- •history of hepatic dysfunction or serum aspartate aminotransferase (AST) ;
- •50 U/L, serum alanine transaminase (ATL) ;
- •50 U/L, or serum bilirubin ;
- •23 µmol/L. Hepatic clearance of the drug has not been studied.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Nitazoxanide
Experimental
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
Days of Cryptosporidium-associated diarrhea
时间窗: 7 days
Time to clearance of Cryptosporidium from stool
时间窗: 6 months
Measured in days
次要结局
- Adverse events, total and stratified by age(6 months)
- Time-to-first Cryptosporidium infection in sibling(6 months)
- Change in weight from baseline to 6 months post-treatment(Baseline, 6 months)
- Change in Lactulose:Mannitol ratio from baseline to 6 months post treatment(Baseline, 6 months)
- Change in height-for-age adjusted z-score from baseline to 6 months post treatment(Baseline, 6 months)
研究者
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