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NCT Number: NCT04289688

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

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).

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Key information

Conditions

Bloodstream Infection Behavior Febrile Illness Health Behavior Health Care Utilization Infections Inflammation Malaria Malaria, Falciparum Malaria,Falciparum Mosquito-Borne Diseases Parasitic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Protozoan Infections Salmonella Infection Non-Typhoid Sepsis Systemic Inflammatory Response Syndrome Treatment Adherence and Compliance Vector Borne Diseases

Age range

28 day–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-Luc Kisantu

Kisantu, Democratic Republic of the Congo

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

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

    Time frame: 7 months

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

    Time frame: 7 months

Secondary outcomes

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

    Time frame: 7 Months

  2. Describe health itinerary based on the three delays model

    Time frame: 7 months

    Stratification will be done according to the confirmed bloodstream infection:

    • non-typhoidal Salmonella (NTS) bloodstream infection,
    • Plasmodium falciparum (Pf) malaria,
    • Pf malaria and bloodstream infection
    • Pf malaria and NTS bloodstream infection

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

    Time frame: 7 months

    Stratification will be done according to the confirmed bloodstream infection:

    • non-typhoidal Salmonella (NTS) bloodstream infection,
    • Plasmodium falciparum (Pf) malaria,
    • Pf malaria and bloodstream infection
    • Pf malaria and NTS bloodstream infection

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

    Time frame: 7 months

    Stratification will be done according to the confirmed bloodstream infection:

    • non-typhoidal Salmonella (NTS) bloodstream infection,
    • Plasmodium falciparum (Pf) malaria,
    • Pf malaria and bloodstream infection
    • Pf malaria and NTS bloodstream infection

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

    Time frame: 7 months

  6. Assess the diagnostic and therapeutic practices before hospital admission per health care provider in hospital admitted children with suspected bloodstream infection

    Time frame: 7 months

  7. Assess the coverage of blood cultures.

    Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium
  • Hôpital Saint-Luc, Kisantu, République Démocratique du Congo
  • Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
  • KU Leuven

Registry information

Official study title

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

Acronym: HIT BSI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Sep 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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