Clinical trial NCT02689193: IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Official title: IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salmonella Septicemia
Salmonella Infections
Fever
Blood Stream Infections
Parasitic Infections
Keywords: Proteomics
Rapid Diagnostic Test
Salmonellosis
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Sihanouk Hospital Center of HOPE
name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Vlaams Instituut voor Biotechnologie
First posted: 2016-02-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults presenting with (a history of) fever and healthy volunteers.

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.

Eligibility 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

Primary outcomes:
measure: Detection of bacterial proteins through Selected Reaction Monitoring (SRM) measured in the unit m/z
timeFrame: 2 years
measure: Quantification of bacterial proteins measured through Selected Reaction Monitoring (SRM) as ion counts
timeFrame: 2 years
measure: Ranking of detected bacterial proteins based on detection per number of samples and on ion counts
timeFrame: 2 years
measure: Colorimetric detection of the selected proteins by ELISA measured in the unit optical density
timeFrame: 2 years
measure: Integration of the selected proteins into a rapid diagnostic test based on a lateral flow format
timeFrame: 4 years
measure: Evaluation of the test expressed as percentage positive in samples
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
state: Flandres
city: Phnom Penh
country: Cambodia
facility: Sihanouk Hospital Center of Hope (SHCH)
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Institut National de Recherche Biomédicale
Study officials:
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
name: Laura Kuijpers, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia
name: Panha Chung
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Ange Landela, MD
role: PRINCIPAL_INVESTIGATOR
References: