NCT03334019

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. 1.To assess seroprevalence of Coxiella burnetii infection among general population, farmers and veterinarians in Western France
  2. 2.To identify risk factors for Coxiella burnetii seropositivity in these populations

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
559

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

November 2, 2017

Last Update Submit

May 28, 2018

Conditions

Q Fever

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (6)

  • Measure of association between Coxiella burnetii seropositivity risk and socio-demographic

    Day 0

  • Measure of association between Coxiella burnetii seropositivity risk and lifestyle

    Day 0

  • Measure of association between Coxiella burnetii seropositivity risk and occupational factors.

    Day 0

  • Measure of association between Coxiella burnetii seropositivity in humans (general population) and cattle herds' prevalence of Coxiella burnetii infection.

    Day 0

  • Measure of association between Coxiella burnetii seropositivity in humans (farmers) and cattle herds' prevalence of Coxiella burnetii infection.

    Day 0

  • +1 more secondary outcomes

Study Arms (1)

subjects

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

Other: blood test

Interventions

blood testOTHER

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

subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* blood donors at blood donation organizations (general population) * beef and dairy cattle farmers * veterinarians involved in a rural practice

You may qualify if:

  • Give a written informed consent
  • Be 18 years old and over
  • Be able to speak French

You may not qualify if:

  • Adults under protection (guardianship or curators)
  • Contraindication for drawing blood

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Nantes

Nantes, 44093, France

RECRUITING

CHU de Nantes

Nantes, 44093, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

All the participants in the study will provide a blood sample

MeSH Terms

Conditions

Q Fever

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Leila Moret, PU-PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Moret, PU-PH

CONTACT

02.40.84.69.24leila.moret@chu-nantes.fr

Marie Pouquet, PharmD

CONTACT

02.40.68.78.21marie.pouquet@oniris-nantes.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 7, 2017

Study Start

November 6, 2017

Primary Completion

May 5, 2018

Study Completion

November 1, 2019

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

FR(2)