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Completed

NCT Number: NCT04473768

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Contribution of handheld diagnostics and point-of-care tests to 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 all pathogen bloodstream infection (NTS and other-pathogen bloodstream infections combined)

  2. Clinical decision support model for bloodstream infection

    Time frame: 12 months

    Develop a clinical decision support model for diagnosis of bloodstream infection caused by all pathogens (NTS and other pathogens combined)

  3. Case fatality

    Time frame: 12 months

    Determine the clinical signs and symptoms associated with case fatality in NTS bloodstream infection and all pathogen bloodstream infections (NTS and other pathogen combined)

  4. Geographical clustering

    Time frame: 12 months

    Assess the geographical clustering of cases with NTS bloodstream infection

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Hôpital St. Luc Kisantu, République Democratique du Congo
  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • International Vaccine Institute
  • KU Leuven

Registry information

Official study title

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

Acronym: DeNTS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2020
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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