TyVECO: Surveillance Protocol

Typhoid Fever Clinical Trial

— TyVECO  

Official title:

An Open-label Effectiveness Study of a Typhoid Conjugate Vaccine in Kisantu, Democratic Republic of Congo (TyVECO) - Step 3: Surveillance Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562102
• Other study ID #: 2020-004
• Status: Recruiting
• Start date: August 9, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: August 2022
• Source: International Vaccine Institute
• Contact: Octavie Lungaya, PhD
• Phone: +243-815-181-121
• Email: octmetila[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48000
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Perforation
• Typhoid Fever

Intervention

Biological:
• Typbar-TCV, Bharat Biotech
Typhoid conjugate vaccine

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Cederi Madimba HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Gare HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Kavwaya HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Kikonka 1 HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Kintanu Etat HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Nkandu 1 HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Nkandu 3 HC	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Saint Luc Hospital	Kisantu	Bas-Congo
Congo, The Democratic Republic of the	Wete HC	Kisantu	Bas-Congo

Sponsors (1)

Lead Sponsor	Collaborator
International Vaccine Institute

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Typhoid fever	Blood culture confirmed infection with Salmonella typhi	Three years from the time of vaccination