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

Health Care Utilization Clinical Trial

— HIT BSI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289688
• Other study ID #: ITM202003
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: September 2022
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 784
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 28 Days to 5 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Febrile Illness
• Health Care Utilization
• Infections
• Malaria
• Malaria, Falciparum
• Malaria,Falciparum
• Salmonella Infection Non-Typhoid
• Salmonella Infections
• Sepsis

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Hôpital Saint-Luc Kisantu	Kisantu

Sponsors (5)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	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

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe health itineraries based on the three delays model in hospital admitted children with suspected bloodstream infection		7 months
Primary	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	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
Secondary	Describe health itinerary based on the three delays model	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	7 months
Secondary	Assess which factors influence the duration of the health itinerary, stratified per diagnostic category	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	7 months
Secondary	Assess the association between the duration of the health itinerary and in hospital case fatality	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	7 months
Secondary	Assess the diagnostic, therapeutic and referral practices at referring health centers in hospital admitted children with suspected bloodstream infection		7 months
Secondary	Assess the diagnostic and therapeutic practices before hospital admission per health care provider in hospital admitted children with suspected bloodstream infection		7 months
Secondary	Assess the coverage of blood cultures.		7 months