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.

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.

Study Overview

• Status: Completed
• Conditions: Salmonella Infections; Infection of Bloodstream
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 96

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Tshopo District
    • Kisangani, Tshopo District, Congo, The Democratic Republic of the
      • University of Kisangani, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Environmental presence of NTS in household of index patients	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.	3 months
Genetic relatedness of environmental/household and index patient results	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	3 months
Public health knowledge for blood stream infections caused by NTS in DR Congo	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 months
Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel	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)	3 months

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: KU Leuven; Université de Kisangani
• Investigators: Principal Investigator: Dadi Falay, Pediatrician, University of Kisangani

Publications and helpful links

General Publications

• Falay D, Kuijpers LM, Phoba MF, De Boeck H, Lunguya O, Vakaniaki E, Bertrand S, Mattheus W, Ceyssens PJ, Vanhoof R, Devlieger H, Van Geet C, Verheyen E, Ngbonda D, Jacobs J. Microbiological, clinical and molecular findings of non-typhoidal Salmonella bloodstream infections associated with malaria, Oriental Province, Democratic Republic of the Congo. BMC Infect Dis. 2016 Jun 10;16:271. doi: 10.1186/s12879-016-1604-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Children; Reservoir; Non-Typhoid Salmonella; Invasive blood stream infections; Household environment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterobacteriaceae Infections; Infections; Communicable Diseases; Salmonella Infections
• Other Study ID Numbers: 1113/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No