Clinical trial NCT03073707: Reservoir of Invasive Salmonellosis in Children, DRC
Official title: The Potential Role of the Household Environment as the Reservoir for Invasive Salmonellosis in Children, Kisangani, DR Congo.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salmonella Infections
Infection of Bloodstream
Keywords: Non-Typhoid Salmonella
Invasive blood stream infections
Reservoir
Household environment
Children
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Université de Kisangani
First posted: 2017-03-08
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Environmental presence of NTS in household of index patients
timeFrame: 3 months
measure: Genetic relatedness of environmental/household and index patient results
timeFrame: 3 months
Secondary outcomes:
measure: 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
timeFrame: 3 months
measure: Public health knowledge for blood stream infections caused by NTS in DR Congo
timeFrame: 3 months
measure: Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel
timeFrame: 3 months
Other outcomes:
Locations:
city: Kisangani
country: Congo, The Democratic Republic of the
facility: University of Kisangani, Faculty of Medicine
state: Tshopo District
Study officials:
affiliation: University of Kisangani
name: Dadi Falay, Pediatrician
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.