Reservoir of Invasive Salmonellosis in Children, DRC

Completed

• Conditions: Salmonella Infections; Infection of Bloodstream
• Interventions: Behavioral: Sample collection

• Registration Number: NCT03073707
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-11-16
• Study Start: 2017-01
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

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

Exclusion Criteria

• Refusal of participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Household	Sample collection	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

Primary Outcome Measures

Name	Time	Method
Environmental presence of NTS in household of index patients	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.
Genetic relatedness of environmental/household and index patient results	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

Name	Time	Method
Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel	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)
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	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)
Public health knowledge for blood stream infections caused by NTS in DR Congo	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

Trial Locations

Locations (1)

University of Kisangani, Faculty of Medicine; 🇨🇩 Kisangani, Tshopo District, Congo, The Democratic Republic of the