Bloodstream InfectionDeNTSNCT04473768
Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children
An observational study of Bloodstream Infection and Salmonella Bacteremia, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
Trial summary
In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%). Read more about this study
- Who is it for?
- Ages 28 days to 5 years
- Conditions the study is for
- Bloodstream Infection, Salmonella Bacteremia, Malaria,Falciparum
- How many people
- 1,880 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 31 Jan 2022
- 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 28 days to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Study site: Pediatric ward of St. Luc general referral hospital in Kisantu health zone (Province Kongo Central, DR Congo), further referred to as "Kisantu Hospital" * Capacity: 100 beds, bed occupancy reaches up to 180% * Financial system: Flat fees per admission (10$) * Ongoing blood culture surveillance study: * Routine free-of-charge blood culture sampling \& work-up coordinated by INRB/ITM * Since 2017, blood culture surveillance as a part of typhoid conjugate vaccine study * Epidemiological context: * High burden of non-typhoidal Salmonella (NTS) bloodstream infections * High Plasmodium falciparum (Pf) malaria endemicity * High prevalence of malnutrition
Who may be able to join
- Be a child of > 28 days and < 5 years old
- Be admitted to Kisantu Hospital
- Having a blood cultured sampled according to the criteria for suspected bloodstream infection embedded in the blood culture surveillance, i.e. presence of objective fever, hypothermia or history of fever during past 48 hours + at least one of the following criteria:
- Hypotension, confusion or increased respiratory rate
- Suspicion of severe localized infection: pneumonia, meningitis, osteomyelitis, complicated urinary tract infection, abscess, skin/soft tissue infection or abdominal infection
- Suspicion of typhoid fever
- Suspicion of severe Pf malaria
- Having a caregiver willing and able to provide written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children in Sub-Saharan Africa: a Prospective Cohort Study
In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of bloodstream infection in children and many children are co-infected with Plasmodium falciparum (Pf) malaria. NTS bloodstream infection presents as a non-specific severe febrile illness, which challenges early diagnosis and, as a consequence, prompt and appropriate antibiotic treatment.Moreover, at the first level of care, frontline health workers have limited expertise and diagnostic skills and, as a consequence, clinical danger signs that indicate serious bacterial infections are often overlooked.
Basic handheld diagnostic instruments and point-of-care tests can help to reliably detect danger signs and improve triage, referral and the start of antibiotics, but there is need for field implementation and adoption to low-resource settings. Further, it is known that some clinical signs and symptoms are frequent in NTS bloodstream infections. The integration of these clinical signs and symptoms in a clinical decision support model can facilitate the diagnosis of NTS bloodstream infections and target antibiotic treatment.
The investigators aim to develop such a clinical decision support model based on data from children under five years old admitted to Kisantu district referral hospital in the Democratic republic of the Congo. While developing the model, the investigators will focus on the signs and symptoms that can differentiate NTS bloodstream infection from severe Pf malaria and on the clinical danger signs that can be assessed by handheld diagnostic instruments and point-of-care tests. The deliverable will be a clinical decision support model ready to integrate in an electronic decision support system.
- Keywords
- Bloodstream infection, Salmonella non-typhi, Children under five years, Clinical decision support, Democratic Republic of the Congo, Fever, Febrile illness, Malaria, Anemia, Malnutrition, Bacterial infection
- Medical subject headings
- Sepsis, Malaria, Falciparum, Malaria, Fever, Anemia, Malnutrition, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NTS bloodstream infection | growth of NTS in blood culture | |
| NTS/Pf malaria co-infection | concurrence of current Pf malaria infection and NTS bloodstream infection | |
| Other pathogen bloodstream infections | growth of a pathogen other than NTS in blood culture | |
| Severe Pf malaria mono-infection | defined according to WHO-criteria | |
| Other causes of febrile illness requiring hospital admission | * Current Pf malaria infection: see above * Recent Pf malaria infection: see above * Non-confirmed bloodstream infection without Pf malaria: no growth in blood culture and negative results in all Pf malaria tests * If feasible, severe bacterial localized infections such as pneumonia, meningitis, osteomyelitis, complicated urinary tract infection, abscess, skin/soft tissue infection or abdominal infection, will be assessed and clinically defined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive signs and symptoms
Identify clinical signs and symptoms predictive for and differentiate between:
1.1. NTS bloodstream infection 1.2. severe Pf malaria mono-infection 1.3. NTS/Pf malaria co-infection 1.4. other-pathogen bloodstream infections 1.5. other causes of febrile illness requiring hospital admission
Measured: 12 months
Contribution of handheld diagnostics and point-of-care tests to NTS bloodstream infection diagnosis
Assess the contribution of handheld diagnostic instruments and point-of-care tests to the detection of danger signs associated with NTS bloodstream infection
Measured: 12 months
Clinical decision support model for NTS bloodstream infection
Develop a clinical decision support model for diagnosis of NTS bloodstream infection based on the predictive clinical signs and symptoms associated with NTS bloodstream infections
Measured: 12 months
Secondary outcomes (4)
Contribution of handheld diagnostics and point-of-care tests to bloodstream infection diagnosis
Assess the contribution of handheld diagnostic instruments and point-of-care tests to the detection of danger signs associated with all pathogen bloodstream infection (NTS and other-pathogen bloodstream infections combined)
Measured: 12 months
Clinical decision support model for bloodstream infection
Develop a clinical decision support model for diagnosis of bloodstream infection caused by all pathogens (NTS and other pathogens combined)
Measured: 12 months
Case fatality
Determine the clinical signs and symptoms associated with case fatality in NTS bloodstream infection and all pathogen bloodstream infections (NTS and other pathogen combined)
Measured: 12 months
Geographical clustering
Assess the geographical clustering of cases with NTS bloodstream infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Feb 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bloodstream InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,880 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Institut National de Recherche Biomedicale (INRB), Hôpital St. Luc Kisantu, République Democratique du Congo, International Vaccine Institute
- Responsible party
- Sponsor
- Investigators
- Bieke Tack, MD, Principal investigator, Institute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473768
- Sponsor's protocol ID
- ID ITM202007
- Acronym
- DeNTS
- Status last verified
- Apr 2022
- First submitted
- 13 Jul 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tack B, Vita D, Mbuyamba J, Ntangu E, Vuvu H, Kahindo I, Ngina J, Luyindula A, Nama N, Mputu T, Im J, Jeon H, Marks F, Toelen J, Lunguya O, Jacobs J, Van Calster B. Developing a clinical prediction model to modify empirical antibiotics for non-typhoidal Salmonella bloodstream infection in children under-five in the Democratic Republic of Congo. BMC Infect Dis. 2025 Jan 27;25(1):122. doi: 10.1186/s12879-024-10319-x.
PubMed 39871187
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children in Sub-Saharan Africa: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04473768
- Acronym / sponsor ID
- DeNTS / ID ITM202007
- Keywords
- Bloodstream infection, Salmonella non-typhi, Children under five years, Clinical decision support, Democratic Republic of the Congo, Fever, Febrile illness, Malaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,880 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- KU Leuven, Institut National de Recherche Biomedicale (INRB), Hôpital St. Luc Kisantu, République Democratique du Congo, International Vaccine Institute
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 16 Jul 2020 (actual)
- 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.
In sub-Saharan Africa, non-typhoidal Salmonella (NTS) are a frequent cause of bloodstream infection, display high levels of antibiotic resistance and have a high case fatality rate (15%). In Kisantu hospital in the Democratic Republic of Congo (DR Congo), NTS account for 75% of bloodstream infection in children and many children are co-infected with Plasmodium falciparum (Pf) malaria. NTS bloodstream infection presents as a non-specific severe febrile illness, which challenges early diagnosis and, as a consequence, prompt and appropriate antibiotic treatment.Moreover, at the first level of care, frontline health workers have limited expertise and diagnostic skills and, as a consequence, clinical danger signs that indicate serious bacterial infections are often overlooked.
Basic handheld diagnostic instruments and point-of-care tests can help to reliably detect danger signs and improve triage, referral and the start of antibiotics, but there is need for field implementation and adoption to low-resource settings. Further, it is known that some clinical signs and symptoms are frequent in NTS bloodstream infections. The integration of these clinical signs and symptoms in a clinical decision support model can facilitate the diagnosis of NTS bloodstream infections and target antibiotic treatment.
The investigators aim to develop such a clinical decision support model based on data from children under five years old admitted to Kisantu district referral hospital in the Democratic republic of the Congo. While developing the model, the investigators will focus on the signs and symptoms that can differentiate NTS bloodstream infection from severe Pf malaria and on the clinical danger signs that can be assessed by handheld diagnostic instruments and point-of-care tests. The deliverable will be a clinical decision support model ready to integrate in an electronic decision support system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| NTS bloodstream infection | – | –growth of NTS in blood culture |
| NTS/Pf malaria co-infection | – | –concurrence of current Pf malaria infection and NTS bloodstream infection |
| Other pathogen bloodstream infections | – | –growth of a pathogen other than NTS in blood culture |
| Severe Pf malaria mono-infection | – | –defined according to WHO-criteria |
| Other causes of febrile illness requiring hospital admission | – | –* Current Pf malaria infection: see above * Recent Pf malaria infection: see above * Non-confirmed bloodstream infection without Pf malaria: no growth in blood culture and negative results in all Pf malaria tests * If feasible, severe bacterial localized infections such as pneumonia, meningitis, osteomyelitis, complicated urinary tract infection, abscess, skin/soft tissue infection or abdominal infection, will be assessed and clinically defined |
Who may qualify
- Ages
- 28 days to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study site: Pediatric ward of St. Luc general referral hospital in Kisantu health zone (Province Kongo Central, DR Congo), further referred to as "Kisantu Hospital" * Capacity: 100 beds, bed occupancy reaches up to 180% * Financial system: Flat fees per admission (10$) * Ongoing blood culture surveillance study: * Routine free-of-charge blood culture sampling \& work-up coordinated by INRB/ITM * Since 2017, blood culture surveillance as a part of typhoid conjugate vaccine study * Epidemiological context: * High burden of non-typhoidal Salmonella (NTS) bloodstream infections * High Plasmodium falciparum (Pf) malaria endemicity * High prevalence of malnutrition
Key inclusion criteria (8 listed)
- Be a child of > 28 days and < 5 years old
- Be admitted to Kisantu Hospital
- Having a blood cultured sampled according to the criteria for suspected bloodstream infection embedded in the blood culture surveillance, i.e. presence of objective fever, hypothermia or history of fever during past 48 hours + at least one of the following criteria:
- Having a caregiver willing and able to provide written informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive signs and symptoms
Time frame: 12 months
Identify clinical signs and symptoms predictive for and differentiate between: 1.1. NTS bloodstream infection 1.2. severe Pf malaria mono-infection 1.3. NTS/Pf malaria co-infection 1.4. other-pathogen bloodstream infections 1.5. other causes of febrile illness requiring hospital admission
Contribution of handheld diagnostics and point-of-care tests to NTS bloodstream infection diagnosis
Time frame: 12 months
Assess the contribution of handheld diagnostic instruments and point-of-care tests to the detection of danger signs associated with NTS bloodstream infection
Clinical decision support model for NTS bloodstream infection
Time frame: 12 months
Develop a clinical decision support model for diagnosis of NTS bloodstream infection based on the predictive clinical signs and symptoms associated with NTS bloodstream infections
4 secondary outcomes
Contribution of handheld diagnostics and point-of-care tests to bloodstream infection diagnosis
Time frame: 12 months
Clinical decision support model for bloodstream infection
Time frame: 12 months
Case fatality
Time frame: 12 months
Geographical clustering
Time frame: 12 months
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 5 Apr 2022.
- Derived from this study: PubMed 39871187Tack B, Vita D, Mbuyamba J, Ntangu E, Vuvu H, Kahindo I, Ngina J, Luyindula A, Nama N, Mputu T, Im J, Jeon H, Marks F, Toelen J, Lunguya O, Jacobs J, Van Calster B. Developing a clinical prediction model to modify empirical antibiotics for non-typhoidal Salmonella bloodstream infection in children under-five in the Democratic Republic of Congo. BMC Infect Dis. 2025 Jan 27;25(1):122. doi: 10.1186/s12879-024-10319-x.
- Individual participant dataSharing planned: Undecided
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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.
Bieke Tack, MD principal investigator
Institute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection and Salmonella Bacteremia, run by Institute of Tropical Medicine, Belgium at 1 site in Belgium.
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 8 inclusion and 1 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Predictive signs and symptoms (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473768, which also lists 1 linked publication.
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 5 Apr 2022.