Q FeverMEDVETFQNCT03334019
Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France
An observational study of Q Fever, run by Nantes University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Q Fever
- What is being tested?
- blood test
- How many people
- 559 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Nov 2017to Nov 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * blood donors at blood donation organizations (general population) * beef and dairy cattle farmers * veterinarians involved in a rural practice
Who may be able to join
- Give a written informed consent
- Be 18 years old and over
- Be able to speak French
Who cannot join
- Adults under protection (guardianship or curators)
- Contraindication for drawing blood
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
- Recruiting
CHU de Nantes
Nantes, 44093
Leila Moret Moret, PU-PH, 02.40.84.69.24 ext. +33, leila.moret@chu-nantes.fr
About this study
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.
Read more
The aims of the study are:
- To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
- To identify risk factors for Coxiella burnetii seropositivity in these populations
Read the 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.
- Conditions
- Q Fever
- Being tested
- blood test
- Medical subject headings
- Q Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood testOther
Data collected on general population, farmers and veterinarians though questionnaires and blood samples.
| Study group | Role | What they receive |
|---|---|---|
| subjects | Data collected on general population, farmers and veterinarians though questionnaires and blood samples. Receives: Other: blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Secondary outcomes (6)
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start6 Nov 2017
- Primary completion5 May 2018
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Q FeverStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 559 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- ONIRIS
- Responsible party
- Sponsor
- Investigators
- Leila Moret, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334019
- Sponsor's protocol ID
- RC16_0420
- Acronym
- MEDVETFQ
- Status last verified
- May 2018
- First submitted
- 2 Nov 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors for Coxiella Burnetii Seropositivity (Q Fever) Among Adults in Western France
- ClinicalTrials.gov ID
- NCT03334019
- Acronym / sponsor ID
- MEDVETFQ / RC16_0420
- Conditions
- Q Fever
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 559 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- ONIRIS
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 7 Nov 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.
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:
- To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
- To identify risk factors for Coxiella burnetii seropositivity in these populations
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects | – | Other: blood testData collected on general population, farmers and veterinarians though questionnaires and blood samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * blood donors at blood donation organizations (general population) * beef and dairy cattle farmers * veterinarians involved in a rural practice
Key inclusion criteria (3 listed)
- Give a written informed consent
- Be 18 years old and over
- Be able to speak French
Key exclusion criteria (2 listed)
- Adults under protection (guardianship or curators)
- Contraindication for drawing blood
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 |
|---|---|---|
| blood testData collected on general population, farmers and veterinarians though questionnaires and blood samples. | Other | subjects |
Primary outcome
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.
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.
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.
6 secondary outcomes
Measure of association between Coxiella burnetii seropositivity risk and socio-demographic
Time frame: Day 0
Measure of association between Coxiella burnetii seropositivity risk and lifestyle
Time frame: Day 0
Measure of association between Coxiella burnetii seropositivity risk and occupational factors.
Time frame: 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
Measure of association between Coxiella burnetii seropositivity in humans (farmers) and cattle herds' prevalence of Coxiella burnetii infection.
Time frame: Day 0
Measure of association between Coxiella burnetii seropositivity in humans ( veterinarians) and cattle herds' prevalence of Coxiella burnetii infection.
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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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.
Leila Moret, PU-PH principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Q Fever, run by Nantes University Hospital at 2 sites in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leila Moret, PU-PH (02.40.84.69.24, leila.moret@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titers against Coxiella burnetii in general population in Western France (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2018.