Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo

NCT04289688 | Completed

• 1 other identifier: ITM202003
• Study Type: observational
• Target: 784
• Locations: 1 country
• Sites: 1

Brief Summary

Bloodstream infections are frequent in children admitted to the hospital for severe febrile illness in sub-Saharan Africa.Ongoing blood culture surveillance at Kisantu Hospital showed non-typhoidal Salmonella (NTS) as the first cause of bloodstream infections in children. Bloodstream infections have a high case fatality (15 - 20%). Outcome of bloodstream infections is dependent on timely diagnosis and treatment. However, observations at Kisantu Hospital showed that many children arrive late and die early after admission. By interviewing caregivers of severely ill children admitted to Kisantu Hospital, the investigators aim to study their health itinerary, i.e. the sequence of all actions of health care seeking and care provision between the onset of febrile illness and the admission at the hospital. The investigators aim to assess the health itinerary according to the "three delays" model. The three delays model studies delays and practices at the level of health care seeking, of transport and of start of antibiotic treatment.10 Visits to referring health centers will provide complementary information about diagnosis, treatment and referral practices. In hospital follow-up will allow to assess the outcome according to the duration of health itinerary. The results of routine laboratory tests upon hospital admission will allow to stratify the health itinerary according to fever etiology. The results of this study will allow to understand the duration of the health itinerary, its possible association with case-fatality, and factors explaining for delays at every level. This information is expected to orient local health policy makers towards interventions shortening the duration of the health itinerary and in that case improve and monitor the referral system. In addition, the study results are expected to orient towards further research to understand health seeking behavior (i.e. focus-group discussions and community-based studies).

Conditions

Bloodstream Infection; Health Care Utilization; Malaria,Falciparum; Salmonella Infection Non-Typhoid; Febrile Illness

Keywords

DR Congo; Three delays model; Health care seeking; Health itinerary; Reaching health care; Severe febrile Illness; Children under 5; Malaria; sub-Saharan Africa

Outcome Measures

Primary Outcomes (2)

• Describe health itineraries based on the three delays model in hospital admitted children with suspected bloodstream infection

  7 months

• Assess which exposure factors variables are associated with the duration of the health itinerary in hospital admitted children with suspected bloodstream infection

  7 months

Secondary Outcomes (7)

• Assess the association between the duration of the health itinerary and in hospital case fatality in hospital admitted children with suspected bloodstream infection

  7 Months

• Describe health itinerary based on the three delays model

  7 months

• Assess which factors influence the duration of the health itinerary, stratified per diagnostic category

  7 months

• Assess the association between the duration of the health itinerary and in hospital case fatality

  7 months

• Assess the diagnostic, therapeutic and referral practices at referring health centers in hospital admitted children with suspected bloodstream infection

  7 months

Eligibility Criteria

• Age: 28 Days - 5 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study setting is the Kisantu health zone, which has a population of 202 451 people, of which 48 043 are under 5 years old. The health zone is subdivided in 17 health areas that are each served by at least one health center, by smaller health posts and by community health workers. The formal health care system is composed of 51 health care facilities. Next to the formal health care system of community health workers, health posts and health centers, many informal health care providers exist (Nurses and doctors provide care, private pharmacies or drug vendors exist and traditional healers). Local disease prevalence: * High P. falciparum malaria endemicity: 24% of children between 6-59 months had a positive blood microscopy test in the last national demographic and health survey. * High prevalence of malnutrition: 46% and 11% of children under five were respectively chronically and acutely malnourished in the last national demographic and health survey.

You may qualify if:

• Be a child between 28 days and 5 years old
• Be admitted to Kisantu Hospital
• Have a suspected bloodstream infection, which is defined as the presence of objective fever, hypothermia or a history of fever during the past 48 hours and 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 malaria
• Having a caregiver willing and able to provide written informed consent

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• KU Leuven: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Fund for Scientific Research, Flanders, Belgium: collaborator
• Hôpital Saint-Luc, Kisantu, République Démocratique du Congo: collaborator

Study Sites (1)

Hôpital Saint-Luc Kisantu

Kisantu, Democratic Republic of the Congo

Location

Related Publications (1)

• Tack B, Vita D, Nketo J, Wasolua N, Ndengila N, Herssens N, Ntangu E, Kasidiko G, Nkoji-Tunda G, Phoba MF, Im J, Jeon HJ, Marks F, Toelen J, Lunguya O, Jacobs J. Health itinerary-related survival of children under-five with severe malaria or bloodstream infection, DR Congo. PLoS Negl Trop Dis. 2023 Mar 6;17(3):e0011156. doi: 10.1371/journal.pntd.0011156. eCollection 2023 Mar.

  PMID: 36877726 DERIVED

MeSH Terms

Conditions

Sepsis; Patient Acceptance of Health Care; Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior; Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Bieke Tack

  Institute of Tropical Medicine Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 28, 2020
• Study Start: February 1, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

DE (1)