Cholera Control by Case-area Targeted Interventions (CATIs)

NCT07685574 | Recruiting DMC

• 1 other identifier: PR-24004
• Study Type: interventional
• Target: 68,400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholera; Methodology Study

Keywords

Cholera; CATI; Cholera Vaccine; Bangladesh

Outcome Measures

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.

  From enrollment to 3 years follow-up period.

Study Arms (3)

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)

Biological: Cholvax

B) the intervention arm receiving two doses at 1-month interval

EXPERIMENTAL

Biological: Cholvax

C) no intervention or control arm

NO INTERVENTION

Interventions

Cholvax BIOLOGICAL

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

A) the intervention arm receiving a single dose; B) the intervention arm receiving two doses at 1-month interval

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Some to severe dehydrated diarrheal patient
• Provide signed informed consent form

You may not qualify if:

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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Wellcome Sanger Institute: collaborator

Study Sites (1)

International Centre for Diarrhoeal Diseases Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

RECRUITING

Related Publications (23)

• 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.

  PMID: 35793924 BACKGROUND

• Kanungo S, Desai SN, Nandy RK, Bhattacharya MK, Kim DR, Sinha A, Mahapatra T, Yang JS, Lopez AL, Manna B, Bannerjee B, Ali M, Dhingra MS, Chandra AM, Clemens JD, Sur D, Wierzba TF. Flexibility of oral cholera vaccine dosing-a randomized controlled trial measuring immune responses following alternative vaccination schedules in a cholera hyper-endemic zone. PLoS Negl Trop Dis. 2015 Mar 12;9(3):e0003574. doi: 10.1371/journal.pntd.0003574. eCollection 2015 Mar.

  PMID: 25764513 BACKGROUND

• Ateudjieu J, Yakum MN, Goura AP, Tembei Ayok M, Guenou E, Kangmo Sielinou CB, Kiadjieu FF, Tsafack M, Douanla Koutio IM, Tchio-Nighie KH, Tchokomeni H, Ntsekendio PN, Sack DA. An innovative approach in monitoring oral cholera vaccination campaign: integration of a between-round survey. BMC Public Health. 2022 Feb 5;22(1):238. doi: 10.1186/s12889-022-12610-5.

  PMID: 35123444 BACKGROUND

• Qadri F, Wierzba TF, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Asaduzzaman M, Akter A, Khan A, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Islam T, Chowdhury AI, Rahman A, Siddique SA, You YA, Kim DR, Siddik AU, Saha NC, Kabir A, Cravioto A, Desai SN, Singh AP, Clemens JD. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh. N Engl J Med. 2016 May 5;374(18):1723-32. doi: 10.1056/NEJMoa1510330.

  PMID: 27144848 BACKGROUND

• Azman AS, Luquero FJ, Ciglenecki I, Grais RF, Sack DA, Lessler J. Correction: The Impact of a One-Dose versus Two-Dose Oral Cholera Vaccine Regimen in Outbreak Settings: A Modeling Study. PLoS Med. 2016 Mar 11;13(3):e1001989. doi: 10.1371/journal.pmed.1001989. eCollection 2016 Mar. No abstract available.

  PMID: 26966905 BACKGROUND

• Sarker MHR, Das SK, Sujon H, Moriyama M, Rahman MM, Uzzaman MN, Banu S, Shahid AS, Das J, Khan SH, Chisti MJ, Faruque A, Ahmed T. Changing Water-Sanitation Determinants of Cholera over Two Decades in Bangladesh. Am J Trop Med Hyg. 2023 Jun 5;109(2):368-375. doi: 10.4269/ajtmh.22-0575. Print 2023 Aug 2.

  PMID: 37277103 BACKGROUND

• Jones FK, Bhuiyan TR, Muise RE, Khan AI, Slater DM, Hutt Vater KR, Chowdhury F, Kelly M, Xu P, Kovac P, Biswas R, Kamruzzaman M, Ryan ET, Calderwood SB, LaRocque RC, Lessler J, Charles RC, Leung DT, Qadri F, Harris JB, Azman AS. Identifying Recent Cholera Infections Using a Multiplex Bead Serological Assay. mBio. 2022 Dec 20;13(6):e0190022. doi: 10.1128/mbio.01900-22. Epub 2022 Oct 26.

  PMID: 36286520 BACKGROUND

• Rahman M, Sack DA, Mahmood S, Hossain A. Rapid diagnosis of cholera by coagglutination test using 4-h fecal enrichment cultures. J Clin Microbiol. 1987 Nov;25(11):2204-6. doi: 10.1128/jcm.25.11.2204-2206.1987.

  PMID: 3693549 BACKGROUND

• Bwire G, Orach CG, Abdallah D, Debes AK, Kagirita A, Ram M, Sack DA. Alkaline peptone water enrichment with a dipstick test to quickly detect and monitor cholera outbreaks. BMC Infect Dis. 2017 Nov 21;17(1):726. doi: 10.1186/s12879-017-2824-8.

  PMID: 29157211 BACKGROUND

• Chowdhury F, Aziz AB, Ahmmed F, Ahmed T, Kang SS, Im J, Park J, Tadesse BT, Islam MT, Kim DR, Hoque M, Pak G, Khanam F, McMillan NAJ, Liu X, Zaman K, Khan AI, Kim JH, Marks F, Qadri F, Clemens JD. The interplay between WASH practices and vaccination with oral cholera vaccines in protecting against cholera in urban Bangladesh: Reanalysis of a cluster-randomized trial. Vaccine. 2023 Mar 31;41(14):2368-2375. doi: 10.1016/j.vaccine.2023.02.054. Epub 2023 Mar 8.

  PMID: 36898931 BACKGROUND

• Qadri F, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Begum YA, Bhuiyan TR, Chowdhury MI, Uddin MJ, Khan JAM, Chowdhury AI, Rahman A, Siddique SA, Asaduzzaman M, Akter A, Khan A, Ae You Y, Siddik AU, Saha NC, Kabir A, Riaz BK, Biswas SK, Begum F, Unicomb L, Luby SP, Cravioto A, Clemens JD. Feasibility and effectiveness of oral cholera vaccine in an urban endemic setting in Bangladesh: a cluster randomised open-label trial. Lancet. 2015 Oct 3;386(10001):1362-1371. doi: 10.1016/S0140-6736(15)61140-0. Epub 2015 Jul 9.

  PMID: 26164097 BACKGROUND

• Azman AS, Parker LA, Rumunu J, Tadesse F, Grandesso F, Deng LL, Lino RL, Bior BK, Lasuba M, Page AL, Ontweka L, Llosa AE, Cohuet S, Pezzoli L, Sodjinou DV, Abubakar A, Debes AK, Mpairwe AM, Wamala JF, Jamet C, Lessler J, Sack DA, Quilici ML, Ciglenecki I, Luquero FJ. Effectiveness of one dose of oral cholera vaccine in response to an outbreak: a case-cohort study. Lancet Glob Health. 2016 Nov;4(11):e856-e863. doi: 10.1016/S2214-109X(16)30211-X.

  PMID: 27765293 BACKGROUND

• Finger F, Bertuzzo E, Luquero FJ, Naibei N, Toure B, Allan M, Porten K, Lessler J, Rinaldo A, Azman AS. The potential impact of case-area targeted interventions in response to cholera outbreaks: A modeling study. PLoS Med. 2018 Feb 27;15(2):e1002509. doi: 10.1371/journal.pmed.1002509. eCollection 2018 Feb.

  PMID: 29485987 BACKGROUND

• Deen J, von Seidlein L. The case for ring vaccinations with special consideration of oral cholera vaccines. Hum Vaccin Immunother. 2018;14(8):2069-2074. doi: 10.1080/21645515.2018.1462068. Epub 2018 May 11.

  PMID: 29630444 BACKGROUND

• Qadri F, Ali M, Lynch J, Chowdhury F, Khan AI, Wierzba TF, Excler JL, Saha A, Islam MT, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Khan IA, Kabir A, Riaz BK, Akter A, Khan A, Asaduzzaman M, Kim DR, Siddik AU, Saha NC, Cravioto A, Singh AP, Clemens JD. Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial. Lancet Infect Dis. 2018 Jun;18(6):666-674. doi: 10.1016/S1473-3099(18)30108-7. Epub 2018 Mar 14.

  PMID: 29550406 BACKGROUND

• Bhattacharya SK, Sur D, Ali M, Kanungo S, You YA, Manna B, Sah B, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Dhingra MS, Donner A, Nair GB, Lopez AL, Wierzba TF, Clemens JD. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2013 Dec;13(12):1050-6. doi: 10.1016/S1473-3099(13)70273-1. Epub 2013 Oct 18.

  PMID: 24140390 BACKGROUND

• Chowdhury F, Ross AG, Islam MT, McMillan NAJ, Qadri F. Diagnosis, Management, and Future Control of Cholera. Clin Microbiol Rev. 2022 Sep 21;35(3):e0021121. doi: 10.1128/cmr.00211-21. Epub 2022 Jun 21.

  PMID: 35726607 BACKGROUND

• Monir MM, Islam MT, Mazumder R, Mondal D, Nahar KS, Sultana M, Morita M, Ohnishi M, Huq A, Watanabe H, Qadri F, Rahman M, Thomson N, Seed K, Colwell RR, Ahmed T, Alam M. Genomic attributes of Vibrio cholerae O1 responsible for 2022 massive cholera outbreak in Bangladesh. Nat Commun. 2023 Mar 1;14(1):1154. doi: 10.1038/s41467-023-36687-7.

  PMID: 36859426 BACKGROUND

• Kaur G, Salem-Bango L, Nery ALMDS, Solomon EC, Ihemezue E, Kelly C, Altare C, Azman AS, Spiegel PB, Lantagne D. Implementation considerations in case-area targeted interventions to prevent cholera transmission in Northeast Nigeria: A qualitative analysis. PLoS Negl Trop Dis. 2023 Apr 28;17(4):e0011298. doi: 10.1371/journal.pntd.0011298. eCollection 2023 Apr.

  PMID: 37115769 BACKGROUND

• Weil AA, Khan AI, Chowdhury F, Larocque RC, Faruque AS, Ryan ET, Calderwood SB, Qadri F, Harris JB. Clinical outcomes in household contacts of patients with cholera in Bangladesh. Clin Infect Dis. 2009 Nov 15;49(10):1473-9. doi: 10.1086/644779.

  PMID: 19842974 BACKGROUND

• Islam MT, Clemens JD, Qadri F. Cholera Control and Prevention in Bangladesh: An Evaluation of the Situation and Solutions. J Infect Dis. 2018 Oct 15;218(suppl_3):S171-S172. doi: 10.1093/infdis/jiy470. No abstract available.

  PMID: 30169839 BACKGROUND

• Harris JB, LaRocque RC, Chowdhury F, Khan AI, Logvinenko T, Faruque AS, Ryan ET, Qadri F, Calderwood SB. Susceptibility to Vibrio cholerae infection in a cohort of household contacts of patients with cholera in Bangladesh. PLoS Negl Trop Dis. 2008 Apr 9;2(4):e221. doi: 10.1371/journal.pntd.0000221.

  PMID: 18398491 BACKGROUND

• Ali M, Nelson AR, Lopez AL, Sack DA. Updated global burden of cholera in endemic countries. PLoS Negl Trop Dis. 2015 Jun 4;9(6):e0003832. doi: 10.1371/journal.pntd.0003832. eCollection 2015.

  PMID: 26043000 BACKGROUND

Related Links

• Global Task Force on Cholera Control: Ending Cholera-A Global Roadmap to 2030
• Shortage of cholera vaccines leads to temporary suspension of two-dose strategy, as cases rise worldwide
• 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
• Technology Transfer and Voluntary Licensing to Address the Global Cholera Vaccine Shortage and Africa's Vaccine Production Goals

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Dr. Fahima Chowdhury, MBBS, MPH, PhD

CONTACT

+8801730016458; fchowdhury@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 6, 2026
• Study Start: September 5, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)