Salmonella SepticemiaIDISNCT02689193
IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
An observational study of Salmonella Septicemia and Salmonella Infections, run by Institute of Tropical Medicine, Belgium at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 2 months and olderHealthy volunteers can take part
- Conditions the study is for
- Salmonella Septicemia, Salmonella Infections, Fever
- What is being tested?
- Blood sampling
- How many people
- 2,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Sep 2014to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children and adults presenting with (a history of) fever and healthy volunteers.
Who may be able to join
- 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
- 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
Show all 10Show fewer
- Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:
- 1. Blood culture request by treating physician
- Adults (≥ 18 years) and children aged 2 months to 18 years with (suspicion of) fever and:
- 1. Blood culture request by treating physician
Who cannot join
- Refusal to participate
- Sihanouk Hospital Center of HOPE (SHCH)
- Refusal to participate
- Not able to give informed consent
- Not able or willing to give informed consent
- A hemoglobin level that is considered too low for weight and age
- Not able or willing to give informed consent
- A hemoglobin level that is considered too low for weight and age
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Democratic Republic of the Congo1 site
Institut National de Recherche Biomédicale
Kinshasa
About this study
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.
Read the 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:
- Patients for whom blood cultures grew Salmonella species
- Patients for whom blood cultures did not grow a pathogen
- Patients for whom blood cultures grew with another pathogen
- 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.
- Conditions
- Salmonella Septicemia, Salmonella Infections, Fever, Blood Stream Infections, Parasitic Infections
- Being tested
- Blood sampling
- Keywords
- Proteomics, Rapid Diagnostic Test, Salmonellosis
- Medical subject headings
- Salmonella Infections, Fever, Parasitic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)
| Study group | Role | What they receive |
|---|---|---|
| Salmonella | Patients for whom blood cultures grew Salmonella species. Receives: 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). Receives: 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). Receives: Other: Blood sampling | |
| Healthy controls | Healthy controls. Patients without fever but from whom blood is drawn for another reason (e.g. check of cholesterol). Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Integration of the selected proteins into a rapid diagnostic test based on a lateral flow format
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startSep 2014
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salmonella SepticemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Sihanouk Hospital Center of HOPE, Institut National de Recherche Biomedicale (INRB), Flemish institute of biotechnology (VIB)
- Responsible party
- Sponsor
- Investigators
- Laura Kuijpers, MD, MSc, Principal investigator, Institute of Tropical Medicine, Antwerp, BelgiumPanha Chung, Principal investigator, Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, CambodiaAnge Landela, MD, Principal investigator, Institut National de Recherche Biomedicale (INRB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689193
- Sponsor's protocol ID
- IDIS
- Acronym
- IDIS
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
- ClinicalTrials.gov ID
- NCT02689193
- Acronym / sponsor ID
- IDIS / IDIS
- Conditions
- Salmonella Septicemia, Salmonella Infections, Fever, Blood Stream Infections, Parasitic Infections
- Keywords
- Proteomics, Rapid Diagnostic Test, Salmonellosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Sihanouk Hospital Center of HOPE, Institut National de Recherche Biomedicale (INRB), Flemish institute of biotechnology (VIB)
- Study start
- Sep 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients for whom blood cultures grew Salmonella species
- Patients for whom blood cultures did not grow a pathogen
- Patients for whom blood cultures grew with another pathogen
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salmonella | – | Other: Blood samplingPatients for whom blood cultures grew Salmonella species. |
| No pathogen | – | Other: Blood samplingPatients 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). |
| Another pathogen | – | Other: Blood samplingPatients 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). |
| Healthy controls | – | Other: Blood samplingHealthy controls. Patients without fever but from whom blood is drawn for another reason (e.g. check of cholesterol). |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children and adults presenting with (a history of) fever and healthy volunteers.
Key inclusion criteria (10 listed)
- 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
- 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
- 1. Blood culture request by treating physician
Key exclusion criteria (8 listed)
- Refusal to participate
- Sihanouk Hospital Center of HOPE (SHCH)
- Refusal to participate
- Not able to give informed consent
- Not able or willing to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra) | Other | Another pathogen, Healthy controls, No pathogen, Salmonella |
Primary outcome
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)
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Kuijpers, MD, MSc principal investigator
Institute of Tropical Medicine, Antwerp, Belgium
Panha Chung principal investigator
Sihanouk Hospital Center of HOPE (SHCH), Phnom Penh, Cambodia
Ange Landela, MD principal investigator
Institut National de Recherche Biomedicale (INRB)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salmonella Septicemia and Salmonella Infections, run by Institute of Tropical Medicine, Belgium at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Cambodia, Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of bacterial proteins through Selected Reaction Monitoring (SRM) measured in the unit m/z (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.