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| Name | Class |
|---|---|
| Wellcome Sanger Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A) the intervention arm receiving a single dose | Experimental | dose (<5 years old children will receive two doses of OCV at 14 days interval according to the WHO guideline) |
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| B) the intervention arm receiving two doses at 1-month interval | Experimental |
| |
| C) no intervention or control arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholvax | Biological | Produced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of culture-confirmed V. cholerae | 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. |
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Index case eligibility
Inclusion Criteria:
Exclusion criteria:
1. Resident in a ward already covered by OCV since 2015
Vaccination Eligibility
Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fahima Chowdhury, MBBS, MPH, PhD | Contact | +8801730016458 | fchowdhury@icddrb.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b) | Recruiting | Dhaka | 1212 | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35793924 | Background | Ratnayake R, Peyraud N, Ciglenecki I, Gignoux E, Lightowler M, Azman AS, Gakima P, Ouamba JP, Sagara JA, Ndombe R, Mimbu N, Ascorra A; Epicentre and MSF CATI Working Group; Welo PO, Mukamba Musenga E, Miwanda B, Boum Y 2nd, Checchi F, Edmunds WJ, Luquero F, Porten K, Finger F. Effectiveness of case-area targeted interventions including vaccination on the control of epidemic cholera: protocol for a prospective observational study. BMJ Open. 2022 Jul 6;12(7):e061206. doi: 10.1136/bmjopen-2022-061206. | |
| 25764513 |
| Label | URL |
|---|---|
| Global Task Force on Cholera Control: Ending Cholera-A Global Roadmap to 2030 | View source |
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| ID | Term |
|---|---|
| D002771 | Cholera |
| ID | Term |
|---|---|
| D014735 | Vibrio Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Background |
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| Shortage of cholera vaccines leads to temporary suspension of two-dose strategy, as cases rise worldwide | View source |
| Millions at risk from cholera due to lack of clean water, soap and toilets, and shortage of cholera vaccine: The International Coordinating Group (ICG) on Vaccine Provision calls for urgent fast-tracking of life-saving measures | View source |
| Technology Transfer and Voluntary Licensing to Address the Global Cholera Vaccine Shortage and Africa's Vaccine Production Goals | View source |
| D007239 | Infections |