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

NCT01450501 | Unknown

• 1 other identifier: 50-51800-98-013
• Study Type: observational
• Target: 999
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

  3 years

Study Arms (1)

Patients with vascular chronic Q-fever

All patients with chronic Q-fever and an aneurysm or vascular reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Patients with a recent central vascular reconstruction (after 1-1-2010) due to a stenoses or occlusion

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (2)

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant, 5200 WB, Netherlands

Location

Bernhoven Hospital

Veghel/Oss, North Brabant, 5460 WB, Netherlands

Location

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).

MeSH Terms

Conditions

Q Fever; Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Julia C.J.P. Hagenaars, MD

  Jeroen Bosch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student, department of Surgery

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 12, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

NL (2)