CholeraNCT04853186
Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance
An observational study of Cholera, run by Epicentre at 1 site in Democratic Republic of the Congo.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholera
- How many people
- 6,000 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 11 May 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
- 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.
Who cannot join
- Patients who decline to participate will be excluded from the study.
- Follow up of individuals with active cholera shedding:
- Individuals who decline to participate will be excluded from the study, as well as households for whom the head of the household (and his or her representative) decline the participation of his/her household.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Flavio Finger contact
Democratic Republic of the Congo1 site, 1 recruiting
- Recruiting
Anais Broban
Goma
Anais BROBAN, 0140215429, anais.broban@epicentre.msf.org
About this study
Official title: 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
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.
Read the detailed description
The project will comprise three different components:
- Clinical cholera surveillance to measure cholera diseases incidence in selected African hotspots targeted by vaccination.
- Serial serological surveys to measure the prevalence of recent cholera infection (within the last 12 months).
- Identification and follow up of individuals with positive V. cholerae shedding (symptomatic or asymptomatic) among sero-survey participants and among household members of cholera confirmed cases.
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:
- To measure cholera incidence rates following the mass vaccination campaign in two cholera hotspots in Africa.
- To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.
- 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.
- To describe the global genetic diversity of V. cholerae strains in the study areas and within households affected by cholera.
- To develop sustainable surveillance methods that could be applied in other hotspots in Africa and elsewhere aiming to monitor the impact of the cholera control program.
- Conditions
- Cholera
- Keywords
- Cholera incidence rates, Mass vaccination campaign, V.Cholerae
- Medical subject headings
- Cholera
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: one year
4. To describe the global genetic diversity of V. cholerae strains in the study areas and within households affected by cholera.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start11 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Médecins Sans Frontières, France, Ministry of Public Health, Democratic Republic of the Congo, Institut National de Recherche Biomedicale (INRB), Grand Labo de Lubumbashi
- Responsible party
- Sponsor
- Investigators
- Klaudia PORTEN, Study director, EpicentreFrancesco Luquero, Study chair, GAVI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853186
- Sponsor's protocol ID
- 2104-WT
- Other IDs
- 215689/Z/19/Z
- Status last verified
- Sep 2024
- First submitted
- 16 Apr 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04853186
- Acronym / sponsor ID
- 2104-WT
- Conditions
- Cholera
- Keywords
- Cholera incidence rates, Mass vaccination campaign, V.Cholerae
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Wellcome Trust, Médecins Sans Frontières, France, Ministry of Public Health, Democratic Republic of the Congo, Institut National de Recherche Biomedicale (INRB), Grand Labo de Lubumbashi
- Study start
- 11 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The project will comprise three different components:
- Clinical cholera surveillance to measure cholera diseases incidence in selected African hotspots targeted by vaccination.
- Serial serological surveys to measure the prevalence of recent cholera infection (within the last 12 months).
- Identification and follow up of individuals with positive V. cholerae shedding (symptomatic or asymptomatic) among sero-survey participants and among household members of cholera confirmed cases.
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:
- To measure cholera incidence rates following the mass vaccination campaign in two cholera hotspots in Africa.
- To assess the duration of shedding among vaccinated and unvaccinated individuals and the duration of viable V. cholerae in the peri-household environment.
- 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.
- To describe the global genetic diversity of V. cholerae strains in the study areas and within households affected by cholera.
- To develop sustainable surveillance methods that could be applied in other hotspots in Africa and elsewhere aiming to monitor the impact of the cholera control program.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- Patients who decline to participate will be excluded from the study.
- Individuals who decline to participate will be excluded from the study, as well as households for whom the head of the household (and his or her representative) decline the participation of his/her household.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 2 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".
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flavio Finger contact
Klaudia PORTEN study director
Epicentre
Francesco Luquero study chair
GAVI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholera, run by Epicentre at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anais BROBAN (+33140215494, anais.broban@epicentre.msf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.