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NCT Number: NCT03073707

Reservoir of Invasive Salmonellosis in Children, DRC

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.

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Key information

Conditions

Salmonella Infections Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infection of Bloodstream Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kisangani, Faculty of Medicine

Kisangani, Tshopo, Democratic Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • Refusal of participation

Treatment and study plan

Sample collection

Behavioral

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.

Primary outcomes

  1. Environmental presence of NTS in household of index patients

    Time frame: 3 months

    Stool 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.

  2. Genetic relatedness of environmental/household and index patient results

    Time frame: 3 months

    Assessment 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 outcomes

  1. Potential demonstration of common source of Salmonella infections in the community by sampling of household environment for NTS, guided by the answers given to questionnaires

    Time frame: 3 months

    Questionnaires 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)

  2. Public health knowledge for blood stream infections caused by NTS in DR Congo

    Time frame: 3 months

    As 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

  3. Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel

    Time frame: 3 months

    If 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)

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • KU Leuven
  • Université de Kisangani

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2017
Registry last updated
Jun 16, 2017

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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