Brief 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 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

48,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach

1 country

9 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

August 9, 2021

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed

Last Updated

September 30, 2022

Status Verified

August 1, 2022

Enrollment Period

2.6 years

First QC Date

September 28, 2022

Last Update Submit

September 28, 2022

Conditions

Typhoid Fever Intestinal Perforation

Outcome Measures

Primary Outcomes (1)

Typhoid fever
Blood culture confirmed infection with Salmonella typhi
Three years from the time of vaccination

Interventions

Typbar-TCV, Bharat BiotechBIOLOGICAL

Typhoid conjugate vaccine

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

Individuals who do not provide informed consent

Contact the study team to confirm eligibility.