TyVECO: Surveillance Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

48000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-09

Study Completion Date

2024-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Typhoid Fever Intestinal Perforation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Typbar-TCV, Bharat Biotech

Typhoid conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

TyVECO: Surveillance Protocol

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Interventions

Typbar-TCV, Bharat Biotech

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

International Vaccine Institute

Responsible Party

Locations

Cederi Madimba HC

Gare HC

Kavwaya HC

Kikonka 1 HC

Kintanu Etat HC

Nkandu 1 HC

Nkandu 3 HC

Saint Luc Hospital

Wete HC

Countries

Central Contacts

Octavie Lungaya, PhD

Justin Im, PhD

Facility Contacts

Jules Mbuyamba, MD

Jules Mbuyamba, MD

Jules Mbuyamba, MD

Jules Mbuyamba, MD

Jules Mbuyamba, MD

Jules Mbuyamba

Jules Mbuyamba, MD

Jules Mbuyamba, MD

Jules Mbuyamba, MD

Other Identifiers

2020-004