- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04473768
Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children (DeNTS)
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Antwerp, Belgium, 2000
- Kisantu general referral hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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NTS bloodstream infection
growth of NTS in blood culture
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NTS/Pf malaria co-infection
concurrence of current Pf malaria infection and NTS bloodstream infection
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Other pathogen bloodstream infections
growth of a pathogen other than NTS in blood culture
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Severe Pf malaria mono-infection
defined according to WHO-criteria
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Other causes of febrile illness requiring hospital admission
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive signs and symptoms
Time Frame: 12 months
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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 |
12 months
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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
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12 months
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Clinical decision support model for NTS bloodstream infection
Time Frame: 12 months
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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
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contribution of handheld diagnostics and point-of-care tests to bloodstream infection diagnosis
Time Frame: 12 months
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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)
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12 months
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Clinical decision support model for bloodstream infection
Time Frame: 12 months
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Develop a clinical decision support model for diagnosis of bloodstream infection caused by all pathogens (NTS and other pathogens combined)
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12 months
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Case fatality
Time Frame: 12 months
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Determine the clinical signs and symptoms associated with case fatality in NTS bloodstream infection and all pathogen bloodstream infections (NTS and other pathogen combined)
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12 months
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Geographical clustering
Time Frame: 12 months
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Assess the geographical clustering of cases with NTS bloodstream infection
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12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bieke Tack, MD, Institute of Tropical Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID ITM202007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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