Bloodstream InfectionHIT BSINCT04289688
Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo
An observational study of Bloodstream Infection and Health Care Utilization, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Ages 28 days to 5 years
- Conditions the study is for
- Bloodstream Infection, Health Care Utilization, Malaria,Falciparum
- How many people
- 784 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Feb 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 5 years
- All sexes
- Child
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Hôpital Saint-Luc Kisantu
Kisantu
About this study
Official title: Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo: a Cohort Study
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).
Read the 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
- Keywords
- DR Congo, Three delays model, Health care seeking, Health itinerary, Reaching health care, Severe febrile Illness, Children under 5, Malaria, sub-Saharan Africa
- Medical subject headings
- Sepsis, Patient Acceptance of Health Care, Malaria, Falciparum, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe health itineraries based on the three delays model in hospital admitted children with suspected bloodstream infection
Measured: 7 months
Assess which exposure factors variables are associated with the duration of the health itinerary in hospital admitted children with suspected bloodstream infection
Measured: 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
Measured: 7 Months
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
Measured: 7 months
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
Measured: 7 months
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
Measured: 7 months
Assess the diagnostic, therapeutic and referral practices at referring health centers in hospital admitted children with suspected bloodstream infection
Measured: 7 months
Assess the diagnostic and therapeutic practices before hospital admission per health care provider in hospital admitted children with suspected bloodstream infection
Measured: 7 months
Assess the coverage of blood cultures.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Feb 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Institut National de Recherche Biomedicale (INRB), Fund for Scientific Research, Flanders, Belgium, Hôpital Saint-Luc, Kisantu, République Démocratique du Congo
- Responsible party
- Sponsor
- Investigators
- Bieke Tack, Principal investigator, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289688
- Sponsor's protocol ID
- ITM202003
- Acronym
- HIT BSI
- Status last verified
- Sep 2022
- First submitted
- 25 Feb 2020
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36877726
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Itinerary of Young Children With Suspected Bloodstream Infection in Kisantu General Referral Hospital, DR Congo: a Cohort Study
- ClinicalTrials.gov ID
- NCT04289688
- Acronym / sponsor ID
- HIT BSI / ITM202003
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 784 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- KU Leuven, Institut National de Recherche Biomedicale (INRB), Fund for Scientific Research, Flanders, Belgium, Hôpital Saint-Luc, Kisantu, République Démocratique du Congo
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 28 days to 5 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe health itineraries based on the three delays model in hospital admitted children with suspected bloodstream infection
Time frame: 7 months
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
7 secondary outcomes
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
Describe health itinerary based on the three delays model
Time frame: 7 months
Assess which factors influence the duration of the health itinerary, stratified per diagnostic category
Time frame: 7 months
Assess the association between the duration of the health itinerary and in hospital case fatality
Time frame: 7 months
Assess the diagnostic, therapeutic and referral practices at referring health centers in hospital admitted children with suspected bloodstream infection
Time frame: 7 months
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
Assess the coverage of blood cultures.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Derived from this study: PubMed 36877726Tack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bieke Tack principal investigator
Institute of Tropical Medicine Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bloodstream Infection and Health Care Utilization, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe health itineraries based on the three delays model in hospital admitted children with suspected bloodstream infection (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04289688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.