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Reservoir of Invasive Salmonellosis in Children, DRC

The Potential Role of the Household Environment as the Reservoir for Invasive Salmonellosis in Children, Kisangani, DR Congo.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03073707
Enrollment
96
Registered
2017-03-08
Start date
2017-01-31
Completion date
2017-04-30
Last updated
2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection of Bloodstream, Salmonella Infections

Keywords

Non-Typhoid Salmonella, Invasive blood stream infections, Reservoir, Household environment, Children

Brief summary

Bloodstream infections caused by non-typhoid Salmonella (NTS) are a major killing disease in Sub-Saharan Africa. Despite the high case fatality rate, the main reservoir -human, zoonotic or environmental- for invasive NTS rests unknown. The main objective of this study is to assess 1. the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and 2. the household water supply for presence of NTS . Households of children with proven NTS invasive infection will be addressed.

Detailed description

This study will be a case-based microbiological assessment of the household environment of index patients presenting with NTS infection. Index patients with laboratory confirmed NTS bloodstream infections will be randomly addressed for the collection of samples from their household (household members, animals (domestic animals and rats) and water supply). The collection of those samples will be done as close as possible to the timing of diagnosis in the index patient. The sites of blood culture collection are the General Hospitals of Makiso and Kabondo and the Centre Hospitalier Village de Pédiatrie. Blood cultures will be drawn by nursing staff according to the standard procedures of the surveillance study. A total of 1500 blood cultures is expected with a positivity rate of 10% (Falay, 2016). According to previous prevalence data in DR Congo, the expected number of NTS in this sample group will be 50 isolates. The isolates of Salmonella sp. conserved on TSA agar will be shipped to ITM and the molecular identity of the isolates will be determined and pairs of isolates (index patient-household environment) will be compared for clonal identity, by whole genome sequencing or equivalent technique as appropriate. A database will be completed that contains the study data. Data that can have a link to the patient identity will be coded.

Interventions

BEHAVIORALSample collection

Stool samples will be collected from household members of children diagnosed with NTS infection. In addition stool samples of animals and rats will be collected as well as samples of the water supply of the household.

Sponsors

Institute of Tropical Medicine, Belgium
Lead SponsorOTHER
KU Leuven
CollaboratorOTHER
Université de Kisangani
CollaboratorUNKNOWN

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Households where at least one child is diagnosed with NTS bloodstream infection * Willing to give informed consent

Exclusion criteria

* Refusal of participation

Design outcomes

Primary

MeasureTime frameDescription
Environmental presence of NTS in household of index patients3 monthsStool samples of rats,animals and household members as well as samples from household water sources will be collected to assess the presence of Salmonella spp.
Genetic relatedness of environmental/household and index patient results3 monthsAssessment of genetic relatedness/clonal identity of Salmonella isolates of index patients, household members and the household environment through whole genome sequencing or equivalent techniques.

Secondary

MeasureTime frameDescription
Potential demonstration of common source of Salmonella infections in the community by sampling of household environment for NTS, guided by the answers given to questionnaires3 monthsQuestionnaires will be conducted in different household. The answers to the questions raised will guide the collection of samples (targeted to water, environment and animal species)
Public health knowledge for blood stream infections caused by NTS in DR Congo3 monthsAs a result of targeted training of household members and the community, knowledge about the prevalence of NTS in the environment will increase, with the aim to avoid blood stream infections caused by NTS
Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel3 monthsIf the results of the study point to a common reservoir of Salmonella NTS in the community, targeted training will be given and control measures explained. The latter will largely depend on the source discovered (e.g. undercooked meat, water source)

Countries

Democratic Republic of the Congo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026