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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ONIRIS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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