Q FeverQ FeverNCT02822807
Q Fever and Auto-immunity
A study testing Blood sampling in people with Q Fever and Auto-Immunity, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Q Fever, Auto-Immunity
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Jan 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a current or former Q fever diagnosis
- Patient > or = 18 years old.
- Patient who does not declined to have his medical records reviewed for research.
- Patient with health insurance.
Who cannot join
- Minor patient (<18 years )
- Adult patient under guardianship .
- Patient deprived of liberty or judgment.
- Patient refusing to sign the informed consent form .
Trial locations and contacts
1 site in 1 country.
About this study
The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.
- Conditions
- Q Fever, Auto-Immunity
- Being tested
- Blood sampling
- 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 samplingBiological
| Study group | Role | What they receive |
|---|---|---|
| Q fever without valvular disease | Other | Q fever without valvular disease Receives: Biological: Blood sampling |
| Q fever with valvular disease | Other | Q fever with valvular disease Receives: Biological: Blood sampling |
| Q fever infective endocarditis | Other | Q fever infective endocarditis Receives: Biological: Blood sampling |
| Other Coxiella burnetii infections (including pregnant women) | Other | Other Coxiella burnetii infections (including pregnant women) Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a complication, linked to the rate of autoantibodies.
The required complications are the followings:
- endocarditis
- thrombosis
- thrombocytopenia
- obstetrical complications:
- Spontaneous miscarriage defined as a spontaneous expulsion of the embryo before 20 weeks gestation .
- Spontaneous abortion
- Fetal intrauterine death
- Oligoamnios
- Intrauterine growth retardation
- Fetal malformations .
Measured: 2 years
Secondary outcomes (2)
Rate of anti- cardiolipin antibodies
Measured: 1 day
Rate of anti- phagosome autoantibodies
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2021
- Study completionJan 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier RAOULT, PR, Principal investigator, Assistance Publique - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822807
- Sponsor's protocol ID
- 2013-31
- Other IDs
- 2013-A00963-42
- Acronym
- Q Fever
- Status last verified
- Oct 2022
- First submitted
- 30 Jun 2016
- Last updated
- 21 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q Fever and Auto-immunity
- ClinicalTrials.gov ID
- NCT02822807
- Acronym / sponsor ID
- Q Fever / 2013-31
- Conditions
- Q Fever, Auto-Immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 4 Jul 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.
The IHU Mediterranean infection is national reference centre for Q fever. Coxiella burnetii is the bacteria responsible of this infection. The bacterium Coxiella burnetii infection is associated with secretion by the body both many antibodies against the bacteria but also against certain cells of the body (autoantibodies). These autoantibodies may have no effect or be associated with specific symptoms. Anti-Phospholipid antibodies are especially prevalent in the Q fever. Apart from this infection, they are associated with thrombocytopenia, obstetric complications, thrombosis and heart valve damage. These conditions have also been described as complications during Q fever. In a retrospective preliminary work on Q fever, we have shown that the presence of high levels of IgG anti-cardiolipin was associated with the presence of valvular and the evolution to endocarditis. Such associations have a therapeutic involvement and must therefore be confirmed. Indeed, if these associations were confirmed, a trans-esophageal ultrasound could be systematically proposed to patients with valvular disease of trans-thoracique ultrasound but IgG anticardiolipin high levels. Other special attention could be given to patients with high autoantibodies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Q fever without valvular disease | Other | Biological: Blood samplingQ fever without valvular disease |
| Q fever with valvular disease | Other | Biological: Blood samplingQ fever with valvular disease |
| Q fever infective endocarditis | Other | Biological: Blood samplingQ fever infective endocarditis |
| Other Coxiella burnetii infections (including pregnant women) | Other | Biological: Blood samplingOther Coxiella burnetii infections (including pregnant women) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a current or former Q fever diagnosis
- Patient > or = 18 years old.
- Patient who does not declined to have his medical records reviewed for research.
- Patient with health insurance.
Key exclusion criteria (4 listed)
- Minor patient (<18 years )
- Adult patient under guardianship .
- Patient deprived of liberty or judgment.
- Patient refusing to sign the informed consent form .
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 sampling | Biological | Other Coxiella burnetii infections (including pregnant women), Q fever infective endocarditis, Q fever with valvular disease, Q fever without valvular disease |
Primary outcome
Occurrence of a complication, linked to the rate of autoantibodies.
Time frame: 2 years
The required complications are the followings: * endocarditis * thrombosis * thrombocytopenia * obstetrical complications: * Spontaneous miscarriage defined as a spontaneous expulsion of the embryo before 20 weeks gestation . * Spontaneous abortion * Fetal intrauterine death * Oligoamnios * Intrauterine growth retardation * Fetal malformations .
2 secondary outcomes
Rate of anti- cardiolipin antibodies
Time frame: 1 day
Rate of anti- phagosome autoantibodies
Time frame: 1 day
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 21 Apr 2023.
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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.
Didier RAOULT, PR principal investigator
Assistance Publique - Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Q Fever and Auto-Immunity, run by Assistance Publique Hopitaux De Marseille at 1 site 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 4 inclusion and 4 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 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Occurrence of a complication, linked to the rate of autoantibodies. (time frame: 2 years). 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 21 Apr 2023.