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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073707
• Other study ID #: 1113/16
• Status: Completed
• Phase: N/A
• First received: November 16, 2016
• Last updated: June 15, 2017
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: June 2017
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Households where at least one child is diagnosed with NTS bloodstream infection

• Willing to give informed consent

Exclusion Criteria:

• Refusal of participation

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	University of Kisangani, Faculty of Medicine	Kisangani	Tshopo District

Sponsors (3)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium	Katholieke Universiteit Leuven, Université de Kisangani

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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