NCT03073707

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. 1.the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and
  2. 2.the household water supply for presence of NTS .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

3 months

First QC Date

November 16, 2016

Last Update Submit

June 15, 2017

Conditions

Salmonella InfectionsInfection of Bloodstream

Keywords

Non-Typhoid SalmonellaInvasive blood stream infectionsReservoirHousehold environmentChildren

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

  • Public health knowledge for blood stream infections caused by NTS in DR Congo

    3 months

  • Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel

    3 months

Study Arms (1)

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

Interventions

Sample collectionBEHAVIORAL

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.

Household

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kisangani, Faculty of Medicine

Kisangani, Tshopo, Democratic Republic of the Congo

Location

Related 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.

    PMID: 27286886BACKGROUND

MeSH Terms

Conditions

Salmonella InfectionsSepsis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Enterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Dadi Falay, Pediatrician

    University of Kisangani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

March 8, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 16, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)