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

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ClinicalTrials.gov Identifier: NCT04289688
Recruitment Status : Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
KU Leuven
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Fund for Scientific Research, Flanders, Belgium
Hôpital Saint-Luc, Kisantu, République Démocratique du Congo
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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).


Condition or disease
Bloodstream Infection Health Care Utilization Malaria,Falciparum Salmonella Infection Non-Typhoid Febrile Illness

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo: a Cohort Study
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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.
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289688


Contacts
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Contact: Bieke Tack 03 247 67 76 ext +32 btack@itg.be
Contact: Jan Jacobs 03 247 66 30 ext +32 jjacobs@itg.be

Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
KU Leuven
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
Fund for Scientific Research, Flanders, Belgium
Hôpital Saint-Luc, Kisantu, République Démocratique du Congo
Investigators
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Principal Investigator: Bieke Tack Institute of Tropical Medicine Antwerp
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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT04289688    
Other Study ID Numbers: ITM202003
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Tropical Medicine, Belgium:
DR Congo
Three delays model
Health care seeking
Health itinerary
Reaching health care
Severe febrile Illness
Children under 5
Malaria
sub-Saharan Africa
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Salmonella Infections
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections