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

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ClinicalTrials.gov Identifier: NCT02689193
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Sihanouk Hospital Center of HOPE
Institut National de Recherche Biomédicale
Vlaams Instituut voor Biotechnologie
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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.

Condition or disease Intervention/treatment
Salmonella Septicemia Salmonella Infections Fever Blood Stream Infections Parasitic Infections Other: Blood sampling

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.


Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Study Start Date : September 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Group/Cohort Intervention/treatment
Salmonella
Patients for whom blood cultures grew Salmonella species.
Other: Blood sampling
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).
Other: Blood sampling
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).
Other: Blood sampling
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).
Other: Blood sampling
Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)




Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. Integration of the selected proteins into a rapid diagnostic test based on a lateral flow format [ Time Frame: 4 years ]
  6. Evaluation of the test expressed as percentage positive in samples [ Time Frame: 4 years ]
    Evaluation of the test on the collected blood and urine samples expressed as percentage positive in Salmonella positive and Salmonella negative samples


Biospecimen Retention:   Samples Without DNA
Whole blood, plasma, serum and urine.


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children and adults presenting with (a history of) fever and healthy volunteers.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689193


Locations
Belgium
Institute of Tropical Medicine
Antwerp, Flandres, Belgium, 2000
Cambodia
Sihanouk Hospital Center of Hope (SHCH)
Phnom Penh, Cambodia
Congo, The Democratic Republic of the
Institut National de Recherche Biomédicale
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
Sihanouk Hospital Center of HOPE
Institut National de Recherche Biomédicale
Vlaams Instituut voor Biotechnologie
Investigators
Principal Investigator: Laura Kuijpers, MD, MSc Institute of Tropical Medicine, Antwerp, Belgium
Principal Investigator: Panha Chung Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia
Principal Investigator: Ange Landela, MD Institut National de Recherche Biomédicale

Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT02689193     History of Changes
Other Study ID Numbers: IDIS
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Keywords provided by Institute of Tropical Medicine, Belgium:
Proteomics
Rapid Diagnostic Test
Salmonellosis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Sepsis
Parasitic Diseases
Salmonella Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections