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

NCT02689193 | Completed

• 1 other identifier: IDIS
• Study Type: observational
• Target: 2,500
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Keywords

Proteomics; Rapid Diagnostic Test; Salmonellosis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• Integration of the selected proteins into a rapid diagnostic test based on a lateral flow format

  4 years

• 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

Study Arms (4)

Salmonella

Patients for whom blood cultures grew Salmonella species.

Other: Blood sampling

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

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

Healthy controls

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

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Another pathogen; Healthy controls; No pathogen; Salmonella

Eligibility Criteria

• Age: 2 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children and adults presenting with (a history of) fever and healthy volunteers.

You may qualify if:

• Adults (≥ 18 years) and children aged 3 years to 18 years with (suspicion of) fever and:
• 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
• presenting at ITM travel clinic for routine check-up ("apparently healthy")
• with recent (\< 2 weeks) stay in tropical country

You may not qualify if:

• Refusal to participate
• B. Sihanouk Hospital Center of HOPE (SHCH)
• Adults (≥ 18 years) with (suspicion of) fever and:
• \. 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
• Refusal to participate
• Not able to give informed consent
• Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:
• \. Blood culture request by treating physician
• Not able or willing to give informed consent
• A hemoglobin level that is considered too low for weight and age
• Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:
• \. Blood culture request by treating physician
• Not able or willing to give informed consent
• A hemoglobin level that is considered too low for weight and age

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Sihanouk Hospital Center of HOPE: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Vlaams Instituut voor Biotechnologie: collaborator

Study Sites (3)

Institute of Tropical Medicine

Antwerp, Flanders, 2000, Belgium

Location

Sihanouk Hospital Center of Hope (SHCH)

Phnom Penh, Cambodia

Location

Institut National de Recherche Biomédicale

Kinshasa, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, plasma, serum and urine.

MeSH Terms

Conditions

Salmonella Infections; Fever; Parasitic Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• 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. Kinshasa, République Démocratique du Congo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 23, 2016
• Study Start: September 1, 2014
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

DE (1); BE (1); CA (1)