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

NCT ID: NCT02689193

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-08-31

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 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:

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 another pathogen

4. 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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Salmonella

Patients for whom blood cultures grew Salmonella species.

Blood sampling

Intervention Type: OTHER

Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)

No pathogen

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).

Blood sampling

Intervention Type: OTHER

Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)

Another pathogen

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).

Blood sampling

Intervention Type: OTHER

Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)

Healthy controls

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

Blood sampling

Intervention Type: OTHER

Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)

Interventions

Blood sampling

Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)

Intervention Type: OTHER

Eligibility Criteria

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

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

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

1. Blood culture request by treating physician

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

Refusal to participate

B. Sihanouk Hospital Center of HOPE (SHCH)

1. Refusal to participate

2. Not able to give informed consent

1. Not able or willing to give informed consent

2. A hemoglobin level that is considered too low for weight and age

1. Not able or willing to give informed consent

2. A hemoglobin level that is considered too low for weight and age

• Minimum Eligible Age: 2 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sihanouk Hospital Center of HOPE

OTHER

Sponsor Role: collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role: collaborator

Vlaams Instituut voor Biotechnologie

UNKNOWN

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Kuijpers, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine, Antwerp, Belgium

Panha Chung

Role: PRINCIPAL_INVESTIGATOR

Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia

Ange Landela, MD

Role: PRINCIPAL_INVESTIGATOR

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Locations

Institute of Tropical Medicine

Antwerp, Flanders, Belgium

Sihanouk Hospital Center of Hope (SHCH)

Phnom Penh, , Cambodia

Institut National de Recherche Biomédicale

Kinshasa, , Democratic Republic of the Congo

Countries

Belgium; Cambodia; Democratic Republic of the Congo

Other Identifiers

IDIS

Identifier Type: -

Identifier Source: org_study_id