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

NCT ID: NCT04289688

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 784 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-07-31

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).

Detailed Description

The study is designed as a hospital-based cohort study at the pediatric ward of Kisantu general referral hospital. The investigators foresee a study inclusion period of 5 months. The study period is currently determined as such that it includes approximately 2 months of the dry season and 3 months of the rainy season. Seasonality is taken into account, because the rain affects the condition of the road and local disease epidemiology and can thus influence the study results. Most data will be collected retrospectively, i.e. all data on the health itinerary collected from the questionnaire and referral letter and the data from the health records in the referring health centers. Only the data from the in-hospital laboratory tests and clinical outcome will be collected prospectively.

The data from the health records at referring health centers will be consulted after termination of the five months study inclusion period to avoid any influence from the study in the patient management at health centers during the study.

Conditions

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

Study Design

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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

-

• 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

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

Hôpital Saint-Luc, Kisantu, République Démocratique du Congo

UNKNOWN

Sponsor Role: collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bieke Tack

Role: PRINCIPAL_INVESTIGATOR

Institute of Tropical Medicine Antwerp

Locations

Hôpital Saint-Luc Kisantu

Kisantu, , Democratic Republic of the Congo

Countries

Democratic Republic of the Congo

References

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.

Reference Type: DERIVED

PMID: 36877726 (View on PubMed)

Other Identifiers

ITM202003

Identifier Type: -

Identifier Source: org_study_id