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Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study) (QAAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01450501
Recruitment Status : Unknown
Verified July 2013 by J.C.J.P. Hagenaars, Jeroen Bosch Ziekenhuis.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2011
Last Update Posted : July 23, 2013
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
J.C.J.P. Hagenaars, Jeroen Bosch Ziekenhuis

Brief 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. 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.

Condition or disease
Chronic Q-fever Aortic Aneurysm, Abdominal Q Fever Aneurysm Vascular Graft Infection

Detailed Description:

Study design:

Prospective observational survey


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

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Study Type : Observational
Estimated Enrollment : 999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)
Study Start Date : March 2011
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Fever

Patients with vascular chronic Q-fever
All patients with chronic Q-fever and an aneurysm or vascular reconstruction

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Prevalence past resolved Q-fever [ Time Frame: 1 year ]
  2. Symptomatology in patients with vascular chronic Q-fever [ Time Frame: 2 years ]
  3. Additional value of the PET/CT-scan as diagnostic tool in patients with an infected aneurysm or vascular graft [ Time Frame: 1,5 years ]
  4. Grow of aneurysm in patients with a vascular chronic Q-fever [ Time Frame: 3 years ]
  5. Surgical intervention in patients with vascular chronic Q-fever [ Time Frame: 3 years ]
    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.

  6. Mortality [ Time Frame: 3 years ]
  7. Conversion rate to chronic Q-fever [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Blood and tissue will be investigated using Polymerase Chain Reaction. Serology for C.burnetii will be investigated in blood using Immunofluorecense assay (focus diagnostics).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Patients with a recent central vascular reconstruction (after 1-1-2010) due to a stenoses or occlusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01450501

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Bernhoven Hospital
Veghel/Oss, Noord Brabant, Netherlands, 5460 WB
Jeroen Bosch Hospital
's Hertogenbosch, Noord- Brabant, Netherlands, 5200 WB
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
ZonMw: The Netherlands Organisation for Health Research and Development
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Principal Investigator: Julia C.J.P. Hagenaars, MD Jeroen Bosch Hospital
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Responsible Party: J.C.J.P. Hagenaars, MD, PhD student, department of Surgery, Jeroen Bosch Ziekenhuis Identifier: NCT01450501    
Other Study ID Numbers: 50-51800-98-013
First Posted: October 12, 2011    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Q Fever
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Vascular Diseases
Cardiovascular Diseases
Body Temperature Changes
Gram-Negative Bacterial Infections
Bacterial Infections