Clinical Trial: IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres

Brief Summary: The IDIS study aims to develop a new rapid diagnostic test for invasive salmonellosis using samples (blood, urine) collected from patients with fever and healthy controls at the Institute of Tropical Medicine (ITM) and collaborating centers. The samples are collected after informed consent and/or assent is given by the participant and are stored in a -80 ⁰C freezer after processing (centrifugation and/or aliquoting). Basic information regarding the patient and the samples are coded and stored in a protected Microsoft Access database. The samples will be shipped to Belgium for proteomic analysis. Identification of Salmonella specific proteins in the samples will hopefully support the development of a rapid diagnostic test. Once this test has been developed, the samples will also be used for validation and evaluation of this test.

Detailed Summary:

The aim of the project is the identification of Salmonella specific proteins that can be detected in samples derived from the host (= humans) during an acute infection. This can support the development of rapid tests to improve the diagnosis of invasive Salmonellosis.

The study is taking place at the travel clinic of the Institute of Tropical Medicine in Antwerp, Belgium, and at the Sihanouk Hospital Center of HOPE in Phnom Penh, Cambodia. It is planned to start in 2016 at the Centre Hospitalier de Kingasani in Kinshasa, Democratic Republic of the Congo in collaboration with the Institut National de Recherche Biomédicale in Kinshasa, Democratic Republic of the Congo. The expected number of participants in total is 2500.

Patients (children and/or adults) presenting with (a history of) fever are asked permission (informed consent and/or assent) to draw additional blood samples (along with routine care samples, so no need for additional venipuncture), and for the long term storage of these samples (whole blood and plasma) in a freezer together with left-over serum and urine samples. They are also asked permission for the collection of coded data including basic demographic, clinical and laboratory data.

Blood for plasma and urine are centrifugated. All samples are aliquoted into cryotubes (coded labelling) before storage in a -80 ⁰C freezer.

Depending on the final diagnosis, patients can be divided in 4 groups:

  1. Patients for whom blood cultures grew Salmonella species
  2. Patients for whom blood cultures did not grow a pathogen
  3. Patients for whom blood cultures grew with an
    Sponsor: Institute of Tropical Medicine, Belgium

    Current Primary Outcome:

    • Detection of bacterial proteins through Selected Reaction Monitoring (SRM) measured in the unit m/z [ Time Frame: 2 years ]
      Detection of bacterial proteins in the collected urine and blood samples through Selected Reaction Monitoring (SRM) measured in the unit m/z (whereby m = the atomic mass and z = the charge of the ion)
    • Quantification of bacterial proteins measured through Selected Reaction Monitoring (SRM) as ion counts [ Time Frame: 2 years ]
      Quantification of bacterial proteins measured through Selected Reaction Monitoring (SRM) as ion counts in the collected urine and blood samples
    • Ranking of detected bacterial proteins based on detection per number of samples and on ion counts [ Time Frame: 2 years ]

      Ranking of detected bacterial proteins based on:

      • Detection of bacterial proteins per number of Salmonella positive and Salmonella negative urine and blood samples
      • Protein abundance measured as ion counts
    • Colorimetric detection of the selected proteins by ELISA measured in the unit optical density [ Time Frame: 2 years ]
      Colorimetric detection of the selected proteins by ELISA measured in the unit optical density (OD) and expressed as percentage present in Salmonella positive and Salmonella negative urine and blood samples
    • Integration of the selected proteins into a rapid diagnostic test based on a lateral flow

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Institute of Tropical Medicine, Belgium

      Dates:
      Date Received: January 29, 2016
      Date Started: September 2014
      Date Completion: August 2019
      Last Updated: September 13, 2016
      Last Verified: August 2016