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

May 28, 2018 updated by: Nantes University Hospital

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

559

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Nantes, France, 44093
        • Recruiting
        • CHU de Nantes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 0
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.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0
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.
Day 0
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.
Day 0
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.
Day 0
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.
Day 0
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.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

ONIRIS

Investigators

  • Principal Investigator: Leila Moret, PU-PH, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2017

Primary Completion (ACTUAL)

May 5, 2018

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 6, 2017

First Posted (ACTUAL)

November 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC16_0420

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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