An observational study in Salmonella Septicemia, Salmonella Infections and Fever, sponsored by Institute of Tropical Medicine, Belgium. Completed at 3 sites in 3 countries. Open to participants aged 2 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by Institute of Tropical Medicine, Belgium · Observational
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.
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:
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Institute of Tropical Medicine, Belgium is the lead sponsor of 103 studies on the registry; 22 are open to participants now.
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Children and adults presenting with (a history of) fever and healthy volunteers.
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:
Exclusion Criteria:
Refusal to participate
B. Sihanouk Hospital Center of HOPE (SHCH)
Inclusion Criteria:
Adults (≥ 18 years) with (suspicion of) fever and:
Exclusion Criteria:
Inclusion Criteria:
Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:
Exclusion Criteria:
Inclusion Criteria:
Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:
Exclusion Criteria:
Patients for whom blood cultures grew Salmonella species.
Other: Blood sampling
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
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. 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)
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 years
Integration of the selected proteins into a rapid diagnostic test based on a lateral flow format
Time frame: 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
Time frame: 4 years
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Institute of Tropical Medicine, Belgium