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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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
J.C.J.P. Hagenaars, Jeroen Bosch Ziekenhuis

Tracking Information
First Submitted Date October 6, 2011
First Posted Date October 12, 2011
Last Update Posted Date July 23, 2013
Study Start Date March 2011
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 10, 2011)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 10, 2011)
  • 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 ]
    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.
  • Mortality [ Time Frame: 3 years ]
  • Conversion rate to chronic Q-fever [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)
Official Title Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)
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:

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and tissue will be investigated using Polymerase Chain Reaction. Serology for C.burnetii will be investigated in blood using Immunofluorecense assay (focus diagnostics).
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.
Condition
  • Chronic Q-fever
  • Aortic Aneurysm, Abdominal
  • Q Fever
  • Aneurysm
  • Vascular Graft Infection
Intervention Not Provided
Study Groups/Cohorts Patients with vascular chronic Q-fever
All patients with chronic Q-fever and an aneurysm or vascular reconstruction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 10, 2011)
999
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2014
Estimated Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT01450501
Other Study ID Numbers 50-51800-98-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party J.C.J.P. Hagenaars, Jeroen Bosch Ziekenhuis
Study 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
PRS Account Jeroen Bosch Ziekenhuis
Verification Date July 2013