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

Malaria,Falciparum Clinical Trial

— DeNTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473768
• Other study ID #: ID ITM202007
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2022
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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%). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1880
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Bloodstream Infection
• Communicable Diseases
• Infections
• Malaria
• Malaria, Falciparum
• Malaria,Falciparum
• Salmonella Bacteremia
• Sepsis
• Severe Malaria

Locations

Country	Name	City	State
Belgium	Kisantu general referral hospital	Antwerp

Sponsors (5)

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

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Primary	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	12 months
Primary	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	12 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	Geographical clustering	Assess the geographical clustering of cases with NTS bloodstream infection	12 months