Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 999
- Locations
- 2
- Primary Endpoint
- Treatment for patients with vascular chronic Q-fever
Study Overview
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.
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- Symptomatology in patients with vascular chronic Q-fever(2 years)
- Surgical intervention in patients with vascular chronic Q-fever(3 years)
- Grow of aneurysm in patients with a vascular chronic Q-fever(3 years)
- Mortality(3 years)
- Conversion rate to chronic Q-fever(1 year)
- Additional value of the PET/CT-scan as diagnostic tool in patients with an infected aneurysm or vascular graft(1,5 years)
- Prevalence past resolved Q-fever(1 year)
Investigators
J.C.J.P. Hagenaars
MD, PhD student, department of Surgery
Jeroen Bosch Ziekenhuis