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

NCT ID: NCT04473768

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1880 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-01-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

NTS bloodstream infection

growth of NTS in blood culture

No interventions assigned to this group

NTS/Pf malaria co-infection

concurrence of current Pf malaria infection and NTS bloodstream infection

No interventions assigned to this group

Other pathogen bloodstream infections

growth of a pathogen other than NTS in blood culture

No interventions assigned to this group

Severe Pf malaria mono-infection

defined according to WHO-criteria

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

OTHER

Sponsor Role: collaborator

Hôpital St. Luc Kisantu, République Democratique du Congo

UNKNOWN

Sponsor Role: collaborator

International Vaccine Institute

OTHER

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bieke Tack, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine

Locations

Kisantu general referral hospital

Antwerp, , Belgium

Countries

Belgium

References

Tack B, Vita D, Mbuyamba J, Ntangu E, Vuvu H, Kahindo I, Ngina J, Luyindula A, Nama N, Mputu T, Im J, Jeon H, Marks F, Toelen J, Lunguya O, Jacobs J, Van Calster B. Developing a clinical prediction model to modify empirical antibiotics for non-typhoidal Salmonella bloodstream infection in children under-five in the Democratic Republic of Congo. BMC Infect Dis. 2025 Jan 27;25(1):122. doi: 10.1186/s12879-024-10319-x.

Reference Type: DERIVED

PMID: 39871187 (View on PubMed)

Other Identifiers

ID ITM202007

Identifier Type: -

Identifier Source: org_study_id