Typhoid FeverTyVECONCT05562102
TyVECO: Surveillance Protocol
An observational study of Typhoid Fever and Intestinal Perforation, run by International Vaccine Institute at 9 sites in Democratic Republic of the Congo.
Trial summary
In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Typhoid Fever, Intestinal Perforation
- What is being tested?
- Typbar-TCV, Bharat Biotech
- Type of treatment
- Vaccines
- How many people
- 48,000 participants
- Where
- 9 sitesDemocratic Republic of the Congo
- Study dates
- 9 Aug 2021to 31 Mar 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The health care structure in the Democratic Republic of Congo is divided into Health Zones, each subdivided into Health Areas. Each Health Area contains first-line Health Posts and second-line Health Centers, which refer patients requiring advanced care to the Health Zone referral hospital. The study population includes both urban and rural areas and includes approximately 200,000 residents. The greatest distance from remote areas to the tertiary hospital is 80km.
Who may be able to join
- At health center:
- Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR
- Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation
- At Hospital:
- Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) OR
- Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares
Who cannot join
- Individuals who do not provide informed consent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Democratic Republic of the Congo9 sites, 9 recruiting
- Recruiting
Cederi Madimba HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, julesngoy9@gmail.com
- Recruiting
Gare HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, julesngoy9@gmail.com
- Recruiting
Kavwaya HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, Julesngoyo9@gmail.com
- Recruiting
Kikonka 1 HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, Julesngoyo9@gmail.com
- Recruiting
Kintanu Etat HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, Julesngoyo9@gmail.com
- Recruiting
Nkandu 1 HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, +243817510066, Julesngoyo9@gmail.com
- Recruiting
Nkandu 3 HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, Julesngoyo9@gmail.com
- Recruiting
Saint Luc Hospital
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, Julesngoyo9@gmail.com
- Recruiting
Wete HC
Kisantu, Bas-Congo Province
Jules Mbuyamba, MD, +243817510066, Julesngoyo9@gmail.com
About this study
Official title: An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 3: Surveillance Protocol
In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. Peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. Biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. Hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.
- Conditions
- Typhoid Fever, Intestinal Perforation
- Being tested
- Typbar-TCV, Bharat Biotech
- Medical subject headings
- Typhoid Fever, Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Typbar-TCV, Bharat BiotechBiological
Typhoid conjugate vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Typhoid fever
Blood culture confirmed infection with Salmonella typhi
Measured: Three years from the time of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start9 Aug 2021
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Typhoid FeverStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562102
- Sponsor's protocol ID
- 2020-004
- Acronym
- TyVECO
- Status last verified
- Aug 2022
- First submitted
- 28 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 3: Surveillance Protocol
- ClinicalTrials.gov ID
- NCT05562102
- Acronym / sponsor ID
- TyVECO / 2020-004
- Conditions
- Typhoid Fever, Intestinal Perforation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48,000 participants (estimated)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 30 Sep 2022 (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.
In Kisantu Health Zone, approximate population 200,000, fever surveillance will be implemented in 8 health centers and 1 tertiary hospital. Individuals presenting to one of these study facilities with acute fever or history of fever or individuals presenting with suspicion of intestinal perforation irrespective of fever status, will be considered for enrollment. Following consent, blood samples (between 2.5 ml for children and 22 ml for adults) will be collected from eligible subjects and demographic and clinical information will be recorded in study forms at the time of enrollment at study health centers and hospitals. Peritoneal fluid and ileal tissue samples will be collected from surgical patients where possible. Biological specimens will be used for various testing, including microbiological culture of blood, tissue and peritoneal fluid for confirmation of bacterial growth, malaria diagnostics (microscopy and rapid testing), and storage of tissue samples for pathological investigation, and biobanking. Hospitalized patients will be followed-up to track clinical outcomes for the duration of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The health care structure in the Democratic Republic of Congo is divided into Health Zones, each subdivided into Health Areas. Each Health Area contains first-line Health Posts and second-line Health Centers, which refer patients requiring advanced care to the Health Zone referral hospital. The study population includes both urban and rural areas and includes approximately 200,000 residents. The greatest distance from remote areas to the tertiary hospital is 80km.
Key inclusion criteria (6 listed)
- Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with objective fever of at least 38.0°C tympanic or 37.5 °C axillary OR
- Patients of all ages currently living in the catchment area of the health center presenting to healthcare facility with reported fever ≥3 consecutive days within 7 days of presentation
- Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgery for patients living in and outside the catchment area (even in the absence of laboratory confirmation) OR
- Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares
Key exclusion criteria (1 listed)
- Individuals who do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Typbar-TCV, Bharat BiotechTyphoid conjugate vaccine | Biological | – |
Primary outcome
Typhoid fever
Time frame: Three years from the time of vaccination
Blood culture confirmed infection with Salmonella typhi
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
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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. This study is not recruiting at the moment.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Typhoid Fever and Intestinal Perforation, run by International Vaccine Institute at 9 sites 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Octavie Lungaya, PhD (+243-815-181-121, octmetila@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Typhoid fever (time frame: Three years from the time of vaccination). 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 30 Sep 2022.