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Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France (MEDVETFQ)

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ClinicalTrials.gov Identifier: NCT03334019
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
ONIRIS
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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

Condition or disease Intervention/treatment
Q Fever Other: blood test

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 559 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : May 5, 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
subjects
Data collected on general population, farmers and veterinarians though questionnaires and blood samples.
Other: blood test
Data collected on general population, farmers and veterinarians though questionnaires and blood samples.




Primary Outcome Measures :
  1. Antibody titers against Coxiella burnetii in general population in Western France [ Time Frame: Day 0 ]
    Blood samples will be taken on blood donors for detection of Coxiella burnetii antibodies by indirect immunofluorescence assay.

  2. Antibody titers against Coxiella burnetii in farmers population in Western France [ Time Frame: Day 0 ]
    Blood samples will be taken on farmers for detection of Coxiella burnetii antibodies by indirect immunofluorescence assay.

  3. Antibody titers against Coxiella burnetii in veterinarians population in Western France [ Time Frame: Day 0 ]
    Blood samples will be taken on veterinarians for detection of Coxiella burnetii antibodies by indirect immunofluorescence assay.


Secondary Outcome Measures :
  1. Measure of association between Coxiella burnetii seropositivity risk and socio-demographic [ Time Frame: Day 0 ]
    A short questionnaire will be filled in by participants (general population) to collect socio-demographic, lifestyle and occupational factors.

  2. Measure of association between Coxiella burnetii seropositivity risk and lifestyle [ Time Frame: Day 0 ]
    A short questionnaire will be filled in by participants (farmers) to collect socio-demographic, lifestyle and occupational factors.

  3. Measure of association between Coxiella burnetii seropositivity risk and occupational factors. [ Time Frame: Day 0 ]
    A short questionnaire will be filled in by participants (veterinarians) to collect socio-demographic, lifestyle and occupational factors.

  4. Measure of association between Coxiella burnetii seropositivity in humans (general population) and cattle herds' prevalence of Coxiella burnetii infection. [ Time Frame: Day 0 ]
    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.

  5. Measure of association between Coxiella burnetii seropositivity in humans (farmers) and cattle herds' prevalence of Coxiella burnetii infection. [ Time Frame: Day 0 ]
    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.

  6. Measure of association between Coxiella burnetii seropositivity in humans ( veterinarians) and cattle herds' prevalence of Coxiella burnetii infection. [ Time Frame: Day 0 ]
    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.


Biospecimen Retention:   Samples Without DNA
All the participants in the study will provide a blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • blood donors at blood donation organizations (general population)
  • beef and dairy cattle farmers
  • veterinarians involved in a rural practice
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334019


Contacts
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Contact: Leila Moret, PU-PH 02.40.84.69.24 leila.moret@chu-nantes.fr
Contact: Marie Pouquet, PharmD 02.40.68.78.21 marie.pouquet@oniris-nantes.fr

Locations
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France
CHU de Nantes Recruiting
Nantes, France, 44093
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Leila Moret Moret, PU-PH    02.40.84.69.24 ext +33    leila.moret@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
ONIRIS
Investigators
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Principal Investigator: Leila Moret, PU-PH Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03334019     History of Changes
Other Study ID Numbers: RC16_0420
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fever
Q Fever
Body Temperature Changes
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections