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

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.

Study Overview

• Status: Unknown
• Conditions: Aneurysm; Aortic Aneurysm, Abdominal; Q Fever; Vascular Graft Infection; 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 Type: Observational
• Enrollment (Anticipated): 999

Contacts and Locations

Study Locations

• Netherlands
  • Noord Brabant
    • Veghel/Oss, Noord Brabant, Netherlands, 5460 WB
      • Bernhoven Hospital
  • Noord- Brabant
    • 's Hertogenbosch, Noord- Brabant, Netherlands, 5200 WB
      • Jeroen Bosch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with vascular chronic Q-fever; All patients with chronic Q-fever and an aneurysm or vascular reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jeroen Bosch Ziekenhuis
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Julia C.J.P. Hagenaars, MD, Jeroen Bosch Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): March 1, 2014

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 10, 2011
• First Posted (Estimate): October 12, 2011

Study Record Updates

• Last Update Posted (Estimate): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Wounds and Injuries; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Diseases; Q Fever
• Other Study ID Numbers: 50-51800-98-013