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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03334019
Other study ID # RC16_0420
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 6, 2017
Est. completion date November 2019

Study information

Verified date May 2018
Source Nantes University Hospital
Contact Leila Moret, PU-PH
Phone 02.40.84.69.24
Email leila.moret@chu-nantes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diseases naturally transmitted between animals and humans (zoonoses) are one of the leading causes of emergence or re-emergence of human infectious diseases. Non-foodborne zoonoses are commonly transmitted to human directly by contact with infected animals or contaminated environment. People working with animals such as farmers and veterinarians are particularly at risk of infection. Some zoonoses can also be transmitted indirectly thought the air and therefore can affect the general population. Example is Q fever, a disease caused by Coxiella burnetii, a bacterium highly resistant in the environment.

In Western France, Q fever is endemic in cattle herds. To improve human zoonotic disease surveillance, the investigators will conduct a population based study in this area.

The aims of the study are:

1. To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France

2. To identify risk factors for Coxiella burnetii seropositivity in these populations


Description:

In order to estimate seroprevalence and risk factors for Coxiella burnetii infection in humans, the investigators will conduct a cross-sectional study in three groups:

- blood donors at blood donation organizations (general population)

- beef and dairy cattle farmers

- veterinarians involved in a rural practice

All the participants in the study will provide a blood sample and will fill in a questionnaire.


Recruitment information / eligibility

Status Recruiting
Enrollment 559
Est. completion date November 2019
Est. primary completion date May 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Give a written informed consent

- Be 18 years old and over

- Be able to speak French

Exclusion Criteria:

- Adults under protection (guardianship or curators)

- Contraindication for drawing blood

Study Design


Related Conditions & MeSH terms


Intervention

Other:
blood test
Data collected on general population, farmers and veterinarians though questionnaires and blood samples.

Locations

Country Name City State
France CHU de Nantes Nantes
France CHU de Nantes Nantes

Sponsors (2)

Lead Sponsor Collaborator
Nantes University Hospital ONIRIS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody titers against Coxiella burnetii in general population in Western France Blood samples will be taken on blood donors for detection of Coxiella burnetii antibodies by indirect immunofluorescence assay. Day 0
Primary Antibody titers against Coxiella burnetii in farmers population in Western France Blood samples will be taken on farmers for detection of Coxiella burnetii antibodies by indirect immunofluorescence assay. Day 0
Primary Antibody titers against Coxiella burnetii in veterinarians population in Western France Blood samples will be taken on veterinarians for detection of Coxiella burnetii antibodies by indirect immunofluorescence assay. Day 0
Secondary Measure of association between Coxiella burnetii seropositivity risk and socio-demographic A short questionnaire will be filled in by participants (general population) to collect socio-demographic, lifestyle and occupational factors. Day 0
Secondary Measure of association between Coxiella burnetii seropositivity risk and lifestyle A short questionnaire will be filled in by participants (farmers) to collect socio-demographic, lifestyle and occupational factors. Day 0
Secondary Measure of association between Coxiella burnetii seropositivity risk and occupational factors. A short questionnaire will be filled in by participants (veterinarians) to collect socio-demographic, lifestyle and occupational factors. Day 0
Secondary Measure of association between Coxiella burnetii seropositivity in humans (general population) and cattle herds' prevalence of Coxiella burnetii infection. Besides blood samples taken on participants, blood samples and milk samples will be taken on beef and dairy cattle herds, respectively, to determine the prevalence of Coxiella burnetii infection in cattle herds. Day 0
Secondary Measure of association between Coxiella burnetii seropositivity in humans (farmers) and cattle herds' prevalence of Coxiella burnetii infection. Besides blood samples taken on participants, blood samples and milk samples will be taken on beef and dairy cattle herds, respectively, to determine the prevalence of Coxiella burnetii infection in cattle herds. Day 0
Secondary Measure of association between Coxiella burnetii seropositivity in humans ( veterinarians) and cattle herds' prevalence of Coxiella burnetii infection. Besides blood samples taken on participants, blood samples and milk samples will be taken on beef and dairy cattle herds, respectively, to determine the prevalence of Coxiella burnetii infection in cattle herds. Day 0
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