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

Fever Clinical Trial

— IDIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689193
• Other study ID #: IDIS
• Status: Completed
• Start date: September 2014
• Est. completion date: August 2019

Study information

• Verified date: February 2020
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Stream Infections
• Communicable Diseases
• Fever
• Infection
• Parasitic Diseases
• Parasitic Infections
• Salmonella Infections
• Salmonella Septicemia
• Sepsis

Intervention

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

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerp	Flandres
Cambodia	Sihanouk Hospital Center of Hope (SHCH)	Phnom Penh
Congo, The Democratic Republic of the	Institut National de Recherche Biomédicale	Kinshasa

Sponsors (4)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo, Sihanouk Hospital Center of HOPE, Vlaams Instituut voor Biotechnologie

Countries where clinical trial is conducted

Belgium,  Cambodia,  Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of bacterial proteins through Selected Reaction Monitoring (SRM) measured in the unit m/z	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)	2 years
Primary	Quantification of bacterial proteins measured through Selected Reaction Monitoring (SRM) as ion counts	Quantification of bacterial proteins measured through Selected Reaction Monitoring (SRM) as ion counts in the collected urine and blood samples	2 years
Primary	Ranking of detected bacterial proteins based on detection per number of samples and on ion counts	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	2 years
Primary	Colorimetric detection of the selected proteins by ELISA measured in the unit optical density	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	2 years
Primary	Integration of the selected proteins into a rapid diagnostic test based on a lateral flow format		4 years
Primary	Evaluation of the test expressed as percentage positive in samples	Evaluation of the test on the collected blood and urine samples expressed as percentage positive in Salmonella positive and Salmonella negative samples	4 years