TyVECO: Surveillance Protocol

Last updated: September 28, 2022
Sponsor: International Vaccine Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intra-abdominal Infections

Treatment

N/A

Clinical Study ID

NCT05562102
2020-004
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: At health center:

  1. Patients of all ages currently living in the catchment area of the health centerpresenting 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 centerpresenting to healthcare facility with reported fever ≥3 consecutive days within 7days of presentation At Hospital:
  3. Suspicion of intestinal perforation/peritonitis due to typhoid fever requiring surgeryfor patients living in and outside the catchment area (even in the absence oflaboratory confirmation) OR
  4. Patients living in the catchment area of the hospital with invasive salmonellosisconfirmed through blood-culture surveillance embedded in routine patient cares

Exclusion

Exclusion Criteria:

  • Individuals who do not provide informed consent

Study Design

Total Participants: 48000
Study Start date:
August 09, 2021
Estimated Completion Date:
March 31, 2024

Connect with a study center

  • Cederi Madimba HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Gare HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Kavwaya HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Kikonka 1 HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Kintanu Etat HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Nkandu 1 HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Nkandu 3 HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Saint Luc Hospital

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Wete HC

    Kisantu, Bas-Congo
    Congo, The Democratic Republic of the

    Active - Recruiting

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