TyVECO: Surveillance Protocol (TyVECO)

September 28, 2022 updated by: International Vaccine Institute

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

48000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Congo, The Democratic Republic of the
    • Bas-Congo
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Cederi Madimba HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Gare HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Kavwaya HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Kikonka 1 HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Kintanu Etat HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Nkandu 1 HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Nkandu 3 HC
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Saint Luc Hospital
        • Contact:
      • Kisantu, Bas-Congo, Congo, The Democratic Republic of the
        • Recruiting
        • Wete HC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

At health center:

  1. 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
  2. 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:

  1. 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
  2. Patients living in the catchment area of the hospital with invasive salmonellosis confirmed through blood-culture surveillance embedded in routine patient cares

Exclusion Criteria:

  • Individuals who do not provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Typhoid fever
Time Frame: Three years from the time of vaccination
Blood culture confirmed infection with Salmonella typhi
Three years from the time of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Vaccine Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 9, 2021

Primary Completion (ANTICIPATED)

March 31, 2024

Study Completion (ANTICIPATED)

March 31, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (ACTUAL)

September 30, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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