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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
J.C.J.P. Hagenaars, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier:
NCT01450501
First received: October 6, 2011
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Q-fever in Patients With an Abdominal Aortic Disease (QAAD-study)

Resource links provided by NLM:


Further study details as provided by Jeroen Bosch Ziekenhuis:

Primary Outcome Measures:
  • Treatment for patients with vascular chronic Q-fever [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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:
  • Prevalence past resolved Q-fever [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Symptomatology in patients with vascular chronic Q-fever [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Additional value of the PET/CT-scan as diagnostic tool in patients with an infected aneurysm or vascular graft [ Time Frame: 1,5 years ] [ Designated as safety issue: Yes ]
  • Grow of aneurysm in patients with a vascular chronic Q-fever [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Surgical intervention in patients with vascular chronic Q-fever [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Conversion rate to chronic Q-fever [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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).


Estimated Enrollment: 999
Study Start Date: March 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with vascular chronic Q-fever
All patients with chronic Q-fever and an aneurysm or vascular reconstruction

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450501

Locations
Netherlands
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
Investigators
Principal Investigator: Julia C.J.P. Hagenaars, MD Jeroen Bosch Hospital
  More Information

No publications provided

Responsible Party: J.C.J.P. Hagenaars, MD, PhD student, department of Surgery, Jeroen Bosch Ziekenhuis
ClinicalTrials.gov Identifier: NCT01450501     History of Changes
Other Study ID Numbers: 50-51800-98-013
Study First Received: October 6, 2011
Last Updated: July 22, 2013
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Diseases
Fever
Q Fever
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on August 20, 2014