TyVECO: Surveillance Protocol

• Conditions: Intestinal Perforation; Typhoid Fever

• Registration Number: NCT05562102
• Lead Sponsor: International Vaccine Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-09
• Status Verified: 2022-08
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Last Update Submitted: 2022-09-28
• Study First Posted: 2022-09-30
• Last Update Posted: 2022-09-30
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (9)

Nkandu 1 HC; 🇨🇩 Kisantu, Bas-Congo, Congo, The Democratic Republic of the

Kintanu Etat HC; 🇨🇩 Kisantu, Bas-Congo, Congo, The Democratic Republic of the

Nkandu 3 HC; 🇨🇩 Kisantu, Bas-Congo, 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

Saint Luc Hospital; 🇨🇩 Kisantu, Bas-Congo, Congo, The Democratic Republic of the

Wete HC; 🇨🇩 Kisantu, Bas-Congo, Congo, The Democratic Republic of the