Chronic Q-feverQAADNCT01450501
Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)
An observational study of Chronic Q-fever and Aortic Aneurysm, Abdominal, run by Jeroen Bosch Ziekenhuis at 2 sites in Netherlands.
Trial summary
Q-fever is a zoonosis caused by Coxiella burnetii, an intracellular bacterium. Since the epidemic outbreak of acute Q-fever in Holland nearly 4030 people have been registered with the acute form of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Q-fever, Aortic Aneurysm, Abdominal, Q Fever
- How many people
- 999 participants
- Where
- 2 sitesNetherlands
- Study dates
- Mar 2011to Mar 2014
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This cohort will be selected from patients with an abdominal aortic disease living in an endemic area after an outbreak of acute Q-fever.
Who may be able to join
- Patients with an aneurysm of the abdominal aorta or iliac arteries of any size.
- Patients with a central vascular reconstruction, such as EVAR, aortic graft and bifurcation graft.
Who cannot join
- Patients with a recent central vascular reconstruction (after 1-1-2010) due to a stenoses or occlusion
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, 5200 WB
Bernhoven Hospital
Veghel/Oss, North Brabant, 5460 WB
About this study
Q-fever is a zoonosis caused by Coxiella burnetii, an intracellular bacterium. Since the epidemic outbreak of acute Q-fever in Holland nearly 4030 people have been registered with the acute form of the disease. Knowing that only 40% of all infected people develop symptoms, the number of infected people (and potential candidates for chronic Q-fever) are much higher. Chronic Q-fever generally manifest itself after a couple of months or years after the primary infection (in 1-5% of all cases). The clinical presentation can be a life-threatening and frequently underdiagnosed disease, as endocarditis, infected aneurysm and vascular prosthesis or chronic Q-fever related to pregnancy and immunecompromised patients. That's why a screening program is started in the endemic area and trace patients with chronic Q-fever. So eventually, a greater group of patients with chronic vascular Q-fever can be described. In addition, there is still no therapeutic guideline for management of chronic Q-fever in patient with a vascular chronic Q-fever.
Patients with an aneurysm or vascular graft will be screened for chronic Q-fever. Patients with chronic Q-fever will be included in a follow-up program, in which additional research and treatment will start. The initial treatment of patients with chronic Q-fever is doxycycline and hydroxychloroquine for at least 18 months. In addition, patients will be monitored in 3-monthly controls, blood samples and imaging will be done. Parameters as complaints, titers, circulating DNA, grow of aneurysm, complications etc. will be investigated.
Ultimately, the current therapeutic guideline for management of C. burnetii will be evaluated if it can also be applied for patients with vascular chronic Q-fever.
Read the detailed description
Study design:
Prospective observational survey
Domain:
Patients with an abdominal aneurysm or central vascular reconstruction in an endemic area after an outbreak of acute Q-fever.
Data collection:
In Jeroen Bosch Hospital and Bernhoven Hospital all patients with an aneurysm or central vascular reconstruction will be screened for Q-fever. Other hospitals in Holland will only check for Q-fever, if they suspect a patient of having an infected aneurysm or prosthesis.
A patient with chronic Q-fever will enter a multidisciplinary follow-up program. First, a PET/CT-scan will be provided (question; signs of an infected aneurysm/prosthesis)and chronic Q-fever endocarditis will be excluded. The patients will initially be treated with doxycycline 2 dd 100mg and plaquenil 200mg 3dd for at least 18 months. A 3-monthly follow-up will start, in which bloodsample, ultrasounds and PET/CTscan will be performed. Data will be collected in SPSS for analyses.
Definitions; Past resolved Q-fever: Any IgG phase 2 and IgG phase 1 <1:1024 Chronic Q-fever: IgG phase 1 >= 1:1024
- Medical subject headings
- Q Fever, Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with vascular chronic Q-fever | All patients with chronic Q-fever and an aneurysm or vascular reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment for patients with vascular chronic Q-fever
The current therapeutic guideline for chronic Q-fever, doxycycline and hydrochloroquine, will now be evaluated in patients with vascular chronic Q-fever
Measured: 3 years
Secondary outcomes (7)
Prevalence past resolved Q-fever
Measured: 1 year
Symptomatology in patients with vascular chronic Q-fever
Measured: 2 years
Additional value of the PET/CT-scan as diagnostic tool in patients with an infected aneurysm or vascular graft
Measured: 1,5 years
Grow of aneurysm in patients with a vascular chronic Q-fever
Measured: 3 years
Surgical intervention in patients with vascular chronic Q-fever
What number of patients with C.burnetii vascular infection develop an indication for surgery, why and what sort of prosthesis must be used. If a prosthesis is infected, should it be removed or not.
Measured: 3 years
Mortality
Measured: 3 years
Conversion rate to chronic Q-fever
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeroen Bosch Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, J.C.J.P. Hagenaars, Jeroen Bosch Ziekenhuis
- Investigators
- Julia C.J.P. Hagenaars, MD, Principal investigator, Jeroen Bosch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450501
- Sponsor's protocol ID
- 50-51800-98-013
- Acronym
- QAAD
- Status last verified
- Jul 2013
- First submitted
- 6 Oct 2011
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)
- ClinicalTrials.gov ID
- NCT01450501
- Acronym / sponsor ID
- QAAD / 50-51800-98-013
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- Jeroen Bosch ZiekenhuisUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 12 Oct 2011 (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.
Q-fever is a zoonosis caused by Coxiella burnetii, an intracellular bacterium. Since the epidemic outbreak of acute Q-fever in Holland nearly 4030 people have been registered with the acute form of the disease. Knowing that only 40% of all infected people develop symptoms, the number of infected people (and potential candidates for chronic Q-fever) are much higher. Chronic Q-fever generally manifest itself after a couple of months or years after the primary infection (in 1-5% of all cases). The clinical presentation can be a life-threatening and frequently underdiagnosed disease, as endocarditis, infected aneurysm and vascular prosthesis or chronic Q-fever related to pregnancy and immunecompromised patients. That's why a screening program is started in the endemic area and trace patients with chronic Q-fever. So eventually, a greater group of patients with chronic vascular Q-fever can be described. In addition, there is still no therapeutic guideline for management of chronic Q-fever in patient with a vascular chronic Q-fever.
Patients with an aneurysm or vascular graft will be screened for chronic Q-fever. Patients with chronic Q-fever will be included in a follow-up program, in which additional research and treatment will start. The initial treatment of patients with chronic Q-fever is doxycycline and hydroxychloroquine for at least 18 months. In addition, patients will be monitored in 3-monthly controls, blood samples and imaging will be done. Parameters as complaints, titers, circulating DNA, grow of aneurysm, complications etc. will be investigated.
Ultimately, the current therapeutic guideline for management of C. burnetii will be evaluated if it can also be applied for patients with vascular chronic Q-fever.
Detailed description
Study design:
Prospective observational survey
Domain:
Patients with an abdominal aneurysm or central vascular reconstruction in an endemic area after an outbreak of acute Q-fever.
Data collection:
In Jeroen Bosch Hospital and Bernhoven Hospital all patients with an aneurysm or central vascular reconstruction will be screened for Q-fever. Other hospitals in Holland will only check for Q-fever, if they suspect a patient of having an infected aneurysm or prosthesis.
A patient with chronic Q-fever will enter a multidisciplinary follow-up program. First, a PET/CT-scan will be provided (question; signs of an infected aneurysm/prosthesis)and chronic Q-fever endocarditis will be excluded. The patients will initially be treated with doxycycline 2 dd 100mg and plaquenil 200mg 3dd for at least 18 months. A 3-monthly follow-up will start, in which bloodsample, ultrasounds and PET/CTscan will be performed. Data will be collected in SPSS for analyses.
Definitions; Past resolved Q-fever: Any IgG phase 2 and IgG phase 1 <1:1024 Chronic Q-fever: IgG phase 1 >= 1:1024
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with vascular chronic Q-fever | – | –All patients with chronic Q-fever and an aneurysm or vascular reconstruction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort will be selected from patients with an abdominal aortic disease living in an endemic area after an outbreak of acute Q-fever.
Key inclusion criteria (2 listed)
- Patients with an aneurysm of the abdominal aorta or iliac arteries of any size.
- Patients with a central vascular reconstruction, such as EVAR, aortic graft and bifurcation graft.
Key exclusion criteria (1 listed)
- Patients with a recent central vascular reconstruction (after 1-1-2010) due to a stenoses or occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment for patients with vascular chronic Q-fever
Time frame: 3 years
The current therapeutic guideline for chronic Q-fever, doxycycline and hydrochloroquine, will now be evaluated in patients with vascular chronic Q-fever
7 secondary outcomes
Prevalence past resolved Q-fever
Time frame: 1 year
Symptomatology in patients with vascular chronic Q-fever
Time frame: 2 years
Additional value of the PET/CT-scan as diagnostic tool in patients with an infected aneurysm or vascular graft
Time frame: 1,5 years
Grow of aneurysm in patients with a vascular chronic Q-fever
Time frame: 3 years
Surgical intervention in patients with vascular chronic Q-fever
Time frame: 3 years
Mortality
Time frame: 3 years
Conversion rate to chronic Q-fever
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
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.
Julia C.J.P. Hagenaars, MD principal investigator
Jeroen Bosch 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 Chronic Q-fever and Aortic Aneurysm, Abdominal, run by Jeroen Bosch Ziekenhuis at 2 sites in Netherlands.
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 2 inclusion and 1 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 23 Jul 2013. 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 Netherlands. 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?
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?
Treatment for patients with vascular chronic Q-fever (time frame: 3 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 23 Jul 2013.