Cholera Control by Case-area Targeted Interventions (CATIs)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Some to severe dehydrated diarrheal patient

Provide signed informed consent form

Disqualifiers

Aged ≥1 year and non-pregnant

Meeting the definition of IHC and NHC

Provide signed informed consent form

History of taking OCV

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cholvax

    Biological/Vaccine

    Produced in Bangladesh and Licenced by the Directorate of Drug Administration (DGDA) for use in Bangladesh

Treatment groups

68,400 Participants
are divided into 3 treatment groups
Group A: A) the intervention arm receiving a single doseExperimental treatment 1 intervention
Group B: B) the intervention arm receiving two doses at 1-month intervalExperimental treatment 1 intervention
Group C: C) no intervention or control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to 3 years follow-up period.

Secondary outcomes

Other outcomes

Sponsors and contacts

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