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Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children

Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children in Sub-Saharan Africa: a Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04473768
Acronym
DeNTS
Enrollment
1880
Registered
2020-07-16
Start date
2021-02-01
Completion date
2022-01-31
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodstream Infection, Malaria,Falciparum, Salmonella Bacteremia, Severe Malaria

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

Brief 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%). 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.

Interventions

None listed

Sponsors

KU Leuven
CollaboratorOTHER
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
CollaboratorOTHER
Hôpital St. Luc Kisantu, République Democratique du Congo
CollaboratorUNKNOWN
International Vaccine Institute
CollaboratorOTHER
Institute of Tropical Medicine, Belgium
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Days to 5 Years
Healthy volunteers
No

Inclusion criteria

1. Be a child of \> 28 days and \< 5 years old 2. Be admitted to Kisantu Hospital 3. 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 4. Having a caregiver willing and able to provide written informed consent

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Predictive signs and symptoms12 monthsIdentify 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 diagnosis12 monthsAssess 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 infection12 monthsDevelop a clinical decision support model for diagnosis of NTS bloodstream infection based on the predictive clinical signs and symptoms associated with NTS bloodstream infections

Secondary

MeasureTime frameDescription
Contribution of handheld diagnostics and point-of-care tests to bloodstream infection diagnosis12 monthsAssess 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)
Geographical clustering12 monthsAssess the geographical clustering of cases with NTS bloodstream infection
Clinical decision support model for bloodstream infection12 monthsDevelop a clinical decision support model for diagnosis of bloodstream infection caused by all pathogens (NTS and other pathogens combined)
Case fatality12 monthsDetermine the clinical signs and symptoms associated with case fatality in NTS bloodstream infection and all pathogen bloodstream infections (NTS and other pathogen combined)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026