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临床试验/NCT02864433
NCT02864433已完成不适用

Evaluation of a Pilot Program to Introduce Cholera Vaccine in Haiti as Part of Global Cholera Control Efforts

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 2,207 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,207
试验地点
1
主要终点
cholera-related diarrhea

研究概览

简要总结

The investigators aim to evaluated a public health program in Haiti that introduced an oral cholera vaccine as part of comprehensive control efforts for a major cholera epidemic. Although the vaccine (Shanchol(R)) had been demonstrated to be very safe, and effective at preventing cholera in many settings, it had not extensively been used to control an outbreak, and it had not been extensively studied in populations that were previously naive to cholera (i.e. countries that had never had cholera before). This cholera epidemic was the first ever report of cholera in Haiti.

After the cholera vaccination campaign was complete, the investigators aimed to evaluate the field efficacy of the vaccination campaign by evaluating the number of cases of cholera, and determining if cholera patients had been vaccinated. The investigators compared the rate of vaccination in cholera cases to controls from the community that had not had cholera in a case-control study.

The investigators also performed a second study - a bias-indicator study - that enrolled patients with non-cholera diarrhea, and community controls. The role of the bias-indicator study was to evaluate for potential sources of bias, since the investigators could expect that cholera vaccination should have no effect on non-cholera diarrhea.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cholera-related diarrhea

时间窗: We will report diarrhea rates at 60 months after the cholera vaccination campaign

Diarrhea will be determined by clinical symptoms of acute watery diarrhea (3 stools in the past 24 hours). 'Cholera' designation will be determined by rapid test and confirmed by bacteriologic culture.

次要结局

  • non-cholera diarrhea(We will report diarrhea rates at 60 months after the cholera vaccination campaign)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Ivers, MD

Associate Physician

Brigham and Women's Hospital

研究点 (1)

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