Clinical Decision Support in Non-typhoidal Salmonella Bloodstream Infections in Children (DeNTS)

April 4, 2022 updated by: Institute of Tropical Medicine, Belgium

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

Study Type

Observational

Enrollment (Actual)

1880

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antwerp, Belgium, 2000
        • Kisantu general referral hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

12 months
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
12 months
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
12 months

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
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)
12 months
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)
12 months
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)
12 months
Geographical clustering
Time Frame: 12 months
Assess the geographical clustering of cases with NTS bloodstream infection
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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