q FeverE-Q-RUNNCT02898402
Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island
An observational study of q Fever, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
Emergent and infectious diseases are a public health priority on Reunion Island. Amongst public health threats, the infection due to Coxiella burnetii (Q fever) seems to have appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- q Fever
- What is being tested?
- blood sample and questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 3,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant women coming to hospital for delivery
Who may be able to join
- all pregnant women coming to the two maternity hospitals located in the south of Reunion island during inclusion period who have been informed and gave consent to participate to the study.
Who cannot join
- women aged less than 18 years old.
- women who did not give their consent
- women for whom it is not possible to perform the blood sample.
About this study
Emergent and infectious diseases are a public health priority on Reunion Island. Amongst public health threats, the infection due to Coxiella burnetii (Q fever) seems to have appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer.
According to the investigator, the diffusion of C. burnetti is more ancient and such diagnosis have been made in the last 30 years with 80 positive serologies identified between 2005 and 2011.
Read more
Considering the high epidemic power of this disease, its often silent clinical expression and its life-threatening condition, the principal investigator wishes to perform a sero-epidemiological study in order to establish or to reject the risk of emergence of Q fever in Reunion island.
The study will be performed on pregnant women because Q fever is responsible for particular complications during pregnancy and because the number of pregnancy followed on Reunion island is stable from one year to the other. The pregnant women population presenting the same exposure criteria as the general population, this population will be used to extrapolate to the general population of the island.
- Conditions
- q Fever
- Being tested
- blood sample and questionnaire
- 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 sample and questionnaireProcedure or surgery
In addition to normal blood sample performed at entry before delivery, an extra 5 ml blood sample will be taken to establish Q fever serodiagnosis and a short questionnaire will be filled in for clinical and epidemiological data.
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of Coxiella burnetii infection in general population in the south of Reunion island
Q fever seroprevalence obtained from blood samples taken on pregnant women hospitalised for delivery will be used to extrapolate to Reunion island general population Q fever seroprevalence.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionJan 2015
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.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898402
- Sponsor's protocol ID
- 2013/CHU/04
- Acronym
- E-Q-RUN
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island
- ClinicalTrials.gov ID
- NCT02898402
- Acronym / sponsor ID
- E-Q-RUN / 2013/CHU/04
- Conditions
- q Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Emergent and infectious diseases are a public health priority on Reunion Island. Amongst public health threats, the infection due to Coxiella burnetii (Q fever) seems to have appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer.
According to the investigator, the diffusion of C. burnetti is more ancient and such diagnosis have been made in the last 30 years with 80 positive serologies identified between 2005 and 2011.
Considering the high epidemic power of this disease, its often silent clinical expression and its life-threatening condition, the principal investigator wishes to perform a sero-epidemiological study in order to establish or to reject the risk of emergence of Q fever in Reunion island.
The study will be performed on pregnant women because Q fever is responsible for particular complications during pregnancy and because the number of pregnancy followed on Reunion island is stable from one year to the other. The pregnant women population presenting the same exposure criteria as the general population, this population will be used to extrapolate to the general population of the island.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women coming to hospital for delivery
Key inclusion criteria (1 listed)
- all pregnant women coming to the two maternity hospitals located in the south of Reunion island during inclusion period who have been informed and gave consent to participate to the study.
Key exclusion criteria (3 listed)
- women aged less than 18 years old.
- women who did not give their consent
- women for whom it is not possible to perform the blood sample.
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 sample and questionnaireIn addition to normal blood sample performed at entry before delivery, an extra 5 ml blood sample will be taken to establish Q fever serodiagnosis and a short questionnaire will be filled in for clinical and epidemiological data. | Procedure or surgery | – |
Primary outcome
prevalence of Coxiella burnetii infection in general population in the south of Reunion island
Time frame: at inclusion
Q fever seroprevalence obtained from blood samples taken on pregnant women hospitalised for delivery will be used to extrapolate to Reunion island general population Q fever seroprevalence.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of q Fever, run by Centre Hospitalier Universitaire de la Réunion.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of Coxiella burnetii infection in general population in the south of Reunion island (time frame: at inclusion). 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 13 Sep 2016.