International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)
Dhaka, 1212, Bangladesh
Location status: Recruiting
NCT Number: NCT07685574
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.
Interested in participating?
Request Info1 year and older
All sexes
Interventional
Not applicable
Dhaka, 1212, Bangladesh
Location status: Recruiting
Background (brief):
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Index case eligibility
Inclusion criteria
Exclusion criteria
Vaccination Eligibility
Inclusion criteria
Exclusion criteria
Produced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh
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.
Contact information is provided by the study sponsor or research team.
International Centre for Diarrhoeal Disease Research, Bangladesh
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06498817
Bacterial Infections, Bacterial Infections and Mycoses
Mānikganj, Bangladesh
View Trial DetailsNCT06455852
Bacterial Infections, Bacterial Infections and Mycoses
Dhaka, Bangladesh
View Trial DetailsNCT05166850
Bacterial Infections, Bacterial Infections and Mycoses
Bukavu, South Kivu, Democratic Republic of the Congo
View Trial DetailsNCT06003816
Bacterial Infections, Bacterial Infections and Mycoses
Dhaka, Bangladesh
View Trial Details