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

Aortic Aneurysm, Abdominal Clinical Trial

— QAAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01450501
• Other study ID #: 50-51800-98-013
• Status: Active, not recruiting
• Phase: N/A
• First received: October 6, 2011
• Last updated: July 22, 2013
• Start date: March 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2013
• Source: Jeroen Bosch Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 999
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Diseases
• Chronic Q-fever
• Fever
• Q Fever
• Vascular Graft Infection

Locations

Country	Name	City	State
Netherlands	Jeroen Bosch Hospital	's Hertogenbosch	Noord- Brabant
Netherlands	Bernhoven Hospital	Veghel/Oss	Noord Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Jeroen Bosch Ziekenhuis	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 years	Yes
Secondary	Prevalence past resolved Q-fever		1 year	Yes
Secondary	Symptomatology in patients with vascular chronic Q-fever		2 years	Yes
Secondary	Additional value of the PET/CT-scan as diagnostic tool in patients with an infected aneurysm or vascular graft		1,5 years	Yes
Secondary	Grow of aneurysm in patients with a vascular chronic Q-fever		3 years	Yes
Secondary	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.	3 years	Yes
Secondary	Mortality		3 years	Yes
Secondary	Conversion rate to chronic Q-fever		1 year	Yes