Salmonella InfectionsNCT03073707
Reservoir of Invasive Salmonellosis in Children, DRC
An observational study of Salmonella Infections and Infection of Bloodstream, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Salmonella Infections, Infection of Bloodstream
- What is being tested?
- Sample collection
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 96 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Jan 2017to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Households where at least one child is diagnosed with NTS bloodstream infection
- Willing to give informed consent
Who cannot join
- Refusal of participation
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
University of Kisangani, Faculty of Medicine
Kisangani, Tshopo
About this study
Official title: 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
- the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and
- the household water supply for presence of NTS .
Households of children with proven NTS invasive infection will be addressed.
Read the 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.
- Conditions
- Salmonella Infections, Infection of Bloodstream
- Being tested
- Sample collection
- Keywords
- Non-Typhoid Salmonella, Invasive blood stream infections, Reservoir, Household environment, Children
- Medical subject headings
- Salmonella Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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)
Measured: 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
Measured: 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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study startJan 2017
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Salmonella InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Université de Kisangani
- Responsible party
- Sponsor
- Investigators
- Dadi Falay, Pediatrician, Principal investigator, University of Kisangani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073707
- Sponsor's protocol ID
- 1113/16
- Status last verified
- Jun 2017
- First submitted
- 16 Nov 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27286886
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of the Household Environment as the Reservoir for Invasive Salmonellosis in Children, Kisangani, DR Congo.
- ClinicalTrials.gov ID
- NCT03073707
- Acronym / sponsor ID
- 1113/16
- Conditions
- Salmonella Infections, Infection of Bloodstream
- Keywords
- Non-Typhoid Salmonella, Invasive blood stream infections, Reservoir, Household environment, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- KU Leuven, Université de Kisangani
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- the household environment (household member, cattle and pets, rats) for intestinal carriage of NTS and
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Household | – | Behavioral: Sample collectionSample 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Households where at least one child is diagnosed with NTS bloodstream infection
- Willing to give informed consent
Key exclusion criteria (1 listed)
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionStool 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. | Behavioural | Household |
Primary outcome
Environmental presence of NTS in household of index patients
Time frame: 3 months
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.
Genetic relatedness of environmental/household and index patient results
Time frame: 3 months
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 secondary outcomes
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
Time frame: 3 months
Public health knowledge for blood stream infections caused by NTS in DR Congo
Time frame: 3 months
Targeted control prevention measures for blood stream infections caused by NTS in DR Congo by training provided by health personnel
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Background: PubMed 27286886Falay 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.
- Individual participant dataSharing planned: No
Related trials for Salmonella Infections
Not yet recruitingPhase 2
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
Typhoid Carrier, Typhoid Fever
Active, not recruitingPhase 3
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
Typhoid
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults
Salmonella Infections
Not yet recruiting
COMPARISON OF SINGLE VERSUS COMBINATION DRUG THERAPY IN EXTENSIVELY DRUG RESISTANT SALMONELLA TYPHI IN TERMS OF TIME TO DEFERVESCENCE
Typhoid Fever
RecruitingPhase 4
Meropenem vs Azithromycin Efficacy in Case XDR Enteric Fever
Enteric Fever
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dadi Falay, Pediatrician principal investigator
University of Kisangani
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salmonella Infections and Infection of Bloodstream, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Environmental presence of NTS in household of index patients (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03073707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.