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临床试验/NCT07685574
NCT07685574招募中不适用

Case-area Targeted Interventions (CATIs) Among Household Contacts and Neighbouring Households After Defining Cholera Hotspot Areas in Bangladesh: The Effectiveness of OCV and Potential Impact on Cholera Control

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 68,400 人开始时间: 2024年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
68,400
试验地点
1
主要终点
Number of culture-confirmed V. cholerae

研究概览

简要总结

To evaluate the effectiveness of the CATI approach among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city, cholera cases will be enrolled by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka hospital. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The 'Case area targeted interventions' (CATI) will be given by administrating Oral Cholera Vaccine (OCV) with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The passive surveillance for cholera will be followed using the icddr,b hospital, and other health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.

详细描述

Background (brief):

  1. Burden: Annually, 2.8 million cases and 95,000 deaths due to cholera are estimated to occur in cholera-endemic countries of Asia, Latin and Central America, and sub-Saharan Africa. The risk of cholera infection within the household and also around the households of cholera cases is higher than in the overall population. Outbreaks of cholera are unpredictable and can occur both in endemic settings and nonendemic areas depending on environmental conditions, climate change, or any humanitarian crisis where sanitary infrastructure is being disrupted. New phenotypes and genotypes of V. cholerae strains are constantly evolving with outbreaks, resulting in an increased risk of antimicrobial resistance (AMR).
  2. Knowledge gap: Standard cholera outbreak response and traditional vaccination campaign is time consuming, costly and usually delayed. A rapid response comprising an early detection of cholera case, hotspot identification and delivery of a rapid response to households around the case could reduce the transmission of disease. But it is not established that whether this early detection of cases and rapid intervention will reduce cholera transmission, also what number of oral cholera vaccine (OCV) will effectively reduce the transmission.
  3. Relevance: Availability of OCV is scarce but necessary for rapid response as it an effective short-term single intervention to shortened the epidemic period and cholera cases. This study aims to evaluate the effectiveness of the CATI approach (single/two doses at 1-month intervals) among household contacts and their neighbours in the reduction of the incidence of cholera

Hypothesis

Case area targeted intervention with OCV reduce the incidence of cholera after defining cholera hotspot.

Objectives: This study aims to evaluate the effectiveness of the CATI approach (OCV- one dose, two doses at one-month interval) among household contacts in the reduction of cumulative incidence of cholera and explore the genome analysis and immune response of V. cholerae antigen from different hotspots in Dhaka city.

Methods: The investigators will enroll cholera cases (index) by rapid diagnostic test (RDT) from the diarrhoeal patients coming to icddr,b Dhaka Hospital in and around Dhaka city based on our inclusion and exclusion criteria. Hotspots will be defined as the households (HHs) surrounding the RDT-positive cholera case (around 20-40m radius). The CATIs will be given by administrating OCV with either one dose or two doses of OCV 1 month apart among household contacts (≥1-year age and non-pregnant women) and contacts of the contacts residing in the adjacent HHs. The investigators will enrol on average 150 participants in each cluster of the index cases on the same day of the enrolment within the nearest geographic boundary (around 20-40m radius). Passive surveillance for cholera will be followed using the icddr,b hospital, and other selected health facilities. Data on each individual's states of the clusters (e.g., susceptible, exposed, infectious, or recovered) will be tracked throughout the 3 years study follow-up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Index case eligibility
  • Inclusion Criteria:
  • Some to severe dehydrated diarrheal patient
  • Provide signed informed consent form

排除标准

  • 1. Resident in a ward already covered by OCV since 2015
  • Vaccination Eligibility
  • Inclusion Criteria:
  • Aged ≥1 year and non-pregnant
  • Meeting the definition of IHC and NHC
  • Provide signed informed consent form
  • Exclusion criteria:
  • History of taking OCV
  • Currently suffering from diarrhea
  • < 1 year of age
  • Pregnant women (verbally confirmed)

结局指标

主要结局

Number of culture-confirmed V. cholerae

时间窗: From enrollment to 3 years follow-up period.

Number of culture-confirmed V. cholerae within 3 years. Stool samples from participants with diarrhea will be cultured for V. cholerae.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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