Cholera Control by Case-area Targeted Interventions (CATIs)

July 1, 2026 updated by: International Centre for Diarrhoeal Disease Research, Bangladesh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

68400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1212
        • Recruiting
        • International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Index case eligibility

Inclusion Criteria:

  1. Some to severe dehydrated diarrheal patient
  2. Provide signed informed consent form

Exclusion criteria:

1. Resident in a ward already covered by OCV since 2015

Vaccination Eligibility

Inclusion Criteria:

  1. Aged ≥1 year and non-pregnant
  2. Meeting the definition of IHC and NHC
  3. Provide signed informed consent form

Exclusion criteria:

  1. History of taking OCV
  2. Currently suffering from diarrhea
  3. < 1 year of age
  4. Pregnant women (verbally confirmed)
  5. Index case

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A) the intervention arm receiving a single dose
dose (<5 years old children will receive two doses of OCV at 14 days interval according to the WHO guideline)
Biological: Cholvax
Produced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh
Experimental: B) the intervention arm receiving two doses at 1-month interval
Biological: Cholvax
Produced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh
No Intervention: C) no intervention or control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of culture-confirmed V. cholerae
Time Frame: 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.
From enrollment to 3 years follow-up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

Wellcome Sanger Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 17, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 6, 2026

Study Record Updates

Last Update Posted (Actual)

July 6, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-24004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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