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Immune response against Coxiella burnetii in Chronic Q-fever

Recruiting
Conditions
chronic Q-fever
10004018
10002363
Coxiella 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
Inclusion Criteria

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

Exclusion Criteria

Age <18 years

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<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
NameTimeMethod
<p>n.v.t.</p><br>
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