Immune response against Coxiella burnetii in Chronic Q-fever
- Conditions
- chronic Q-fever1000401810002363Coxiella burnetii infection
- Registration Number
- NL-OMON35955
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 990
Chronic Q-fever patients:
- Proven or probable chronic Q fever according to the recent consensus of the Dutch workgroup on Q-fever;Q-fever fatigue syndrome (QFS) patients:
- Laboratory-proven acute Q fever in the 3 years before presentation and/or positive serology fitting a past infection with Coxiella burnetii
- AND being severely fatigued, defined by scoring 35 or higher on the subscale fatigue severity of the CIS
- AND being fatigued for at least 6 months;Patients with past Q-fever infection without chronic infection or QFS
- A history of laboratory-proven acute Q-fever infection by either PCR on sera or serology fitting acute infection
- No chronic sequelae at least after 12 months of follow up;Healthy serologic negative volunteers:
- Negative Q-fever serology;Vascular patients with chronic Q-fever undergoing surgery for infected atherosclerotic aorta aneurysm (AAA) :
- Proven chronic Q-fever infection with infection of the vascular wall seen on CT, PET-CT or ultrasonography
- Necessity of resection;Vascular patients undergoing surgery, either with AAA or AOD
- For patients with uninfected AAA: An aneurysm of the aorta abdominalis for which resection with prosthetic replacement is necessary
- For patients with AOD: An obstructive defect in the aorta or iliacal artery for which resection with prosthetic replacement is necessary ;Seropositive individuals reporting no history of Q-fever
- Serology fitting past infection
- No reported history of acute Q-fever ;Seropositive individuals with a history of acute Q-fever
- A history of proven acute infection by either PCR on sera or serology fitting acute infection
- No chronic sequelae at least after 12 months of follow up;Seropositive individuals with QFS
- Laboratory-proven acute Q fever in the 3 years before presentation and/or positive serology fitting a past infection with Coxiella burnetii
- AND being severely fatigued, defined by scoring 35 or higher on the subscale fatigue severity of the CIS
- AND being fatigued for at least 6 months;Seropositive indivuals with chronic Q-fever
- Proven or probable chronic Q fever according to the recent consensus of the Dutch workgroup on Q-fever;Seronegative individuals (controls) living in the endemic area without a history of Q-fever
- Negative Q-fever serology
- Living in endemic area
Age <18 years
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Circulating cytokine profiles in serum of patients during different stages<br /><br>of the various clinical manifestations of Q-fever.<br /><br><br /><br>2. In-vitro recognition and signalling pathways, cytokine pattern, Th-cell<br /><br>differentiation and macrophage polarisation of peripheral blood immune cells<br /><br>and immune cells isolated from aneurismal aorta wall, after stimulation with C.<br /><br>burnetii components.<br /><br><br /><br>3. Immunohistochemical properties of immune cells in aorta specimens of<br /><br>(Coxiella-infected) AAA patients and mRNA analysis for genes encoding proteins<br /><br>involved in the recognition and signalling of C. burnetii.<br /><br><br /><br>4. Polymorphisms in innate and adaptive immune response genes that may be<br /><br>related to the susceptibility and/or the development of a clinical<br /><br>manifestation of Q-fever.</p><br>
- Secondary Outcome Measures
Name Time Method <p>n.v.t.</p><br>