NCT02047162已完成不适用
Randomized, Double-blind, Placebo-controlled Trial of the Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients in Pakistan
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- use of antimicrobial medications
研究概览
简要总结
The purpose of this study is to learn whether bismuth subsalicylate can reduce use of antibiotics among adults with diarrhea in Pakistan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons aged 15 - 65 years old
- •Presenting with mild to moderate, non-bloody, acute diarrhea (≥3 loose stools/day for <3 days) to participating health care settings
- •For whom the study physicians recommend antimicrobial treatment
排除标准
- •Is pregnant
- •Requires hospitalization
- •Has signs or symptoms of septicemia
- •Has a primary complaint of another acute illness
- •Has a serious chronic illness
- •Has an allergy to aspirin
- •Has been exposed to antimicrobial or antidiarrheal medications within 72 hours of enrollment
- •Previously enrolled in study
研究组 & 干预措施
Bismuth subsalicylate
Experimental
Bismuth subsalicylate, 262 mg/chewable tablet, 2 tablets every hour as needed up to 16 tablets per 24 hours, for up to 48 hours.
干预措施: Bismuth subsalicylate (Drug)
Placebo
Placebo Comparator
Placebo chewable tablets, 2 every hour as needed up to 16 tablets per 24 h, for up to 48 h.
干预措施: Placebo (Other)
结局指标
主要结局
use of antimicrobial medications
时间窗: within 5 days of enrollment
次要结局
- Additional care obtained for diarrheal illness(within 5 days of enrollment)
- additional care obtained for diarrhea(within 48 h of enrollment)
- Disease severity and duration(within 5 days of enrollment)
- Patient experience with the study drug(within 5 days of enrollment)
- Patient's perceived need for antibiotics(Within 48 h of enrollment)
研究者
Anna Bowen
Medical Epidemiologist
Centers for Disease Control and Prevention
研究点 (1)
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