Reservoir of Invasive Salmonellosis in Children, DRC

Salmonella Infections Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infection of Bloodstream
• Salmonella Infections

• NCT number: NCT03073707
• Study type: Observational
• Source: Institute of Tropical Medicine, Belgium
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Completion date: April 2017