Actively Recruiting
Cholera Control in Endemic Regions of Africa: Clinical Surveillance and Cholera Shedding Study in the Context of Mass Vaccination Campaigns, Democratic Republic of the Congo
Led by Epicentre · Updated on 2024-09-19
6000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
E
Epicentre
Lead Sponsor
W
Wellcome Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the impact of oral cholera vaccine mass campaigns in two locations—one urban and one rural—in the Democratic Republic of the Congo (DRC). The goal is to understand how these vaccination efforts affect the control of cholera in areas where the disease is common and causes high mortality. This includes gathering key evidence to guide future cholera vaccine strategies in similar regions. The project includes three parts: clinical surveillance to track cholera cases in selected hotspots, regular blood tests to detect recent cholera infections, and monitoring individuals who test positive for cholera bacteria, whether they show symptoms or not, including their household members. It focuses on assessing cholera incidence after vaccination campaigns and studying how long vaccinated and unvaccinated people shed the bacteria, as well as the spread within households. Participants will be patients attending selected cholera treatment centers and their household members if they test positive for cholera bacteria. Researchers will measure cholera transmission rates over two years, monitor bacterial shedding for up to one year, and analyze the genetic diversity of cholera strains. The study will develop sustainable monitoring methods to track the effectiveness of cholera control programs. Participation involves clinical evaluations and follow-up for up to two years.
CONDITIONS
Brief Title
Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients presenting to selected Cholera Treatment Centers/Units who meet the case definition and provide consent (or assent if aged 8 to 17 years).
- Household members of cholera-positive individuals who have consented to participate, with verbal consent from the household head and individual consent (or assent for children 8 to 17 years).
You will not qualify if you...
- Patients or individuals who decline to participate in the study.
- Households for whom the head of household or their representative declines participation of the household members.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who undergo routine care are observed to measure cholera incidence rates and monitor cholera transmission in hotspot areas following mass vaccination campaigns.
Ongoing clinical surveillance visits as medically indicated
Duration - Up to 1 year
Participants with positive V. cholerae shedding, including both symptomatic and asymptomatic individuals, and their household members are followed to assess duration of bacterial shedding, secondary attack rates, and genetic diversity of V. cholerae strains.
Multiple follow-up visits depending on shedding status and household assessments
Trial Site Locations
Total: 1 location
1
Anais Broban
Goma, Democratic Republic of the Congo
Actively Recruiting
Research Team
A
Anais BROBAN
F
Flavio Finger
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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