Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance
ConditionCholera
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEpicentre
About this trial
This project aims to fill this essential knowledge gap by assessing the impact of oral cholera vaccine mass campaigns in 2 sites (urban and rural) in DRC, described in this protocol. The evidence generated from this project will be key to develop future strategies regarding cholera vaccine use in endemic settings, including places with higher burden in terms of cholera mortality.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients presenting at the time of the study to any selected Cholera Treatment Center/Cholera Treatment Unit (CTC/CTU), matching the case definition and giving his/her consent (or assent for children 8 to 17 years old) to participate in the study will be eligible.
Disqualifiers
Patients who decline to participate will be excluded from the study.
present to any selected CTC/CTU, match the case definition, participate to the clinical surveillance activity and test positive to RDT OR
Be a household member of a person respecting inclusion criteria 1. AND for whom the head of the household has provided verbal consent to participate AND giving his/her consent (or assent for children 8 to 17 years old) to participate in the study will be eligible.
Trial population
All patients presenting to a CTC/UTC with a watery diarrhoea (≥ 3 watery stools per day), with or without vomiting, with or without dehydration. For the follow-up of individuals with active cholera shedding: This activity will take place in the community at included patient's households. Patients will be identified through CTC/CTUs and will therefore be conducted in the catchment area of these structures.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
To better characterize cholera transmission in cholera hotspot in Africa and assess the impact of a large vaccination campaign reaching high coverage on sustained control of cholera transmission for at least two years.
Specific objectives 1 and 4 will be answered through the clinical surveillance activity, below referred to as "Surveillance in study CTCs", while 2 and 3 relate to the follow-up activity, below referred to as "Follow-up of individuals with active cholera shedding".
Time frame
2 yearsSecondary outcomes
1
1. To retrospectively study surveillance data, and prospectively measure cholera incidence rates of medically-attended confirmed cases following the mass vaccination campaign in two cholera hotspots in Africa.
Time frame
2 years2
2. To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.
Time frame
one year3
3. To measure the secondary cholera attack rates (symptomatic and asymptomatic) at household level among vaccinated and unvaccinated individuals following the identification of an index case in a given household.
Time frame
one year4
4. To describe the global genetic diversity of V. cholerae strains in the study areas and within households affected by cholera.
Time frame
2 yearsSponsors and contacts
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Epicentre
Lead sponsor
Wellcome Trust
Collaborator
Médecins Sans Frontières, France
Collaborator
Ministry of Public Health, Democratic Republic of the Congo
Collaborator
Institut National de Recherche Biomédicale. Goma, République Démocratique du Congo
Collaborator
Grand Labo de Lubumbashi
Collaborator
Source ClinicalTrials.gov