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Reservoir of Invasive Salmonellosis in Children, DRC

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ClinicalTrials.gov Identifier: NCT03073707
Recruitment Status : Completed
First Posted : March 8, 2017
Last Update Posted : June 16, 2017
Sponsor:
Collaborators:
KU Leuven
Université de Kisangani
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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.


Condition or disease Intervention/treatment
Salmonella Infections Infection of Bloodstream Behavioral: Sample collection

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.

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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Potential Role of the Household Environment as the Reservoir for Invasive Salmonellosis in Children, Kisangani, DR Congo.
Actual Study Start Date : January 2017
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Household
Sample collection will be anticipated for 20 cases of NTS infections and household/environment in order to analyze 10 combinations of NTS strains in the index patient and its environment
Behavioral: Sample 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The criteria for blood collection in patients are standardized according to the surveillance study. This study was approved by the ethics committee of DR Congo on 07th July 2015. The surveillance study will identify children with Salmonella bacteremia, who will be approached for participation in the household study.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of participation

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): NCT03073707


Locations
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Congo, The Democratic Republic of the
University of Kisangani, Faculty of Medicine
Kisangani, Tshopo District, Congo, The Democratic Republic of the
Sponsors and Collaborators
Institute of Tropical Medicine, Belgium
KU Leuven
Université de Kisangani
Investigators
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Principal Investigator: Dadi Falay, Pediatrician University of Kisangani
Publications:
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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT03073707    
Other Study ID Numbers: 1113/16
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Non-Typhoid Salmonella
Invasive blood stream infections
Reservoir
Household environment
Children
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Salmonella Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections