An observational study in Cholera, sponsored by Epicentre. Recruiting at 1 site in Congo, The Democratic Republic of the. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Epicentre · Observational
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.
The project will comprise three different components:
The present protocol relates to the setup of clinical surveillance and the follow up of individuals with positive V. cholerae shedding identified through clinical surveillance, in DRC.
This protocol will allow us to assess if a large vaccination campaign reaching high coverage in cholera hotspot in Africa can allow sustained control of cholera for at least two years, by fulfilling the following specific objectives:
83 studies on the registry are indexed under Cholera; 16 are open to participants now.
Browse Cholera studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
For Surveillance in study CTCs
Inclusion Criteria:
Exclusion Criteria:
Follow up of individuals with active cholera shedding:
Inclusion Criteria:
Exclusion Criteria:
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 years
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 years
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 year
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 year
4. To describe the global genetic diversity of V. cholerae strains in the study areas and within households affected by cholera.
Time frame: 2 years
Plan to share: Undecided — Datasets gathered during this study are susceptible to be made available to other research groups which are currently actively collaborating with Epicentre in the cholera research projects. In that case, data sharing agreements will be made with the relevant research groups.
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