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

Institute of Tropical Medicine, Belgium

Status: Completed

Conditions: Fever; Parasitic Infections; Blood Stream Infections; Salmonella Infections; Salmonella Septicemia

Treatments: Other: Blood sampling

Study type: Observational

Funder types: Other

Identifiers

NCT02689193

IDIS

Details and patient eligibility

About

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.

Full description

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:

Patients for whom blood cultures grew Salmonella species Patients for whom blood cultures did not grow a pathogen Patients for whom blood cultures grew with another pathogen Healthy controls

The frozen samples collected in Cambodia and the Democratic Republic of the Congo will be shipped to Belgium.

All selection of all the samples collected will undergo proteomic analysis by researchers of the Institute of Tropical Medicine in collaboration with the Vlaams Instituut voor Biotechnologie and coded data related to the samples is shared with these partners.

Once this test has been developed, the samples will also be used for validation and evaluation of this test.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 2+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

A. Travel clinic Institute of Tropical Medicine (ITM) Antwerp

Inclusion Criteria:

Adults (≥ 18 years) and children aged 3 years to 18 years with (suspicion of) fever and:

1. presenting at ITM travel clinic with history of fever (axillary T° ≥ 38°C) and/or chills/rigor and sweats within 3 days prior to consultation
2. presenting at ITM travel clinic for routine check-up ("apparently healthy")
3. with recent (< 2 weeks) stay in tropical country

Exclusion Criteria:

Refusal to participate

B. Sihanouk Hospital Center of HOPE (SHCH)

Inclusion Criteria:

Adults (≥ 18 years) with (suspicion of) fever and:

1. Presenting at the in- and outpatient department of SHCH with a history of fever (axillary T≥ 38°C) and/or/chills/rigor and sweats within 3 days prior to consultation

Exclusion Criteria:

1. Refusal to participate
2. Not able to give informed consent

Inclusion Criteria:

Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:

1. Blood culture request by treating physician

Exclusion Criteria:

1. Not able or willing to give informed consent
2. A hemoglobin level that is considered too low for weight and age

Inclusion Criteria:

Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:

1. Blood culture request by treating physician

Exclusion Criteria:

1. Not able or willing to give informed consent
2. A hemoglobin level that is considered too low for weight and age

Trial design

2,500 participants in 4 patient groups

Salmonella

Description:

Patients for whom blood cultures grew Salmonella species.

Treatment:

Other: Blood sampling

No pathogen

Description:

Patients for whom blood cultures did not grow a pathogen and no pathogen was detected using other routine care diagnostics (e.g. malaria with the use of a malaria rapid test).

Treatment:

Other: Blood sampling

Another pathogen

Description:

Patients for whom blood cultures grew with another pathogen or a pathogen was detected using other routine care diagnostics (e.g. malaria with the use of malaria rapid test).

Treatment:

Other: Blood sampling

Healthy controls

Description:

Healthy controls. Patients without fever but from whom blood is drawn for another reason (e.g. check of cholesterol).

Treatment:

Other: Blood sampling