The role of the immune system in Q Fever Fatigue Syndrome

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Q Fever Fatigue Syndrome (QFS):
•Diagnosis of QFS according to national LCI-guideline Q fever fatigue syndrome (QFS)
•Score >=40 on the subschale fatigue of the Checklist Individual Strength (CIS)
•Severe functional impairment on Sickness Impact Profile-8 (SIP-8), defined as a SIP total score >=700
•Age >=18;Chronic Fatigue Syndrome (CFS):
•Diagnosed with CFS according to CDC-criteria (www.cdc.gov/cfs)
•Score >=40 on the subschale fatigue of the CIS
•Severe functional impairment on Sickness Impact Profile-8 (SIP-8), defined as a SIP total score >=700
•Age >=18;Cleared acute Q fever without residual symptoms:
•Cleared acute Q fever (without residual symptoms)
•Age >=18;Healthy serologic negative volunteers:
•Negative Q fever serology as tested by immunofluorescence assay (IFA)
•Age >=18

Exclusion Criteria

Q Fever Fatigue Syndrome (QFS):
•Use of immunosuppressant drugs during an acute Q fever infection or in the past 3 months
•Pregnancy
•Use of antibiotics that are potentially active against C. Burnetii for at least 4 weeks, after the diagnosis acute Q fever was made;Chronic Fatigue Syndrome (CFS):
•Use of immunosuppressant drugs in the past 3 months
•History of Q fever
•Chronic Q fever patients, according to the Dutch consensus *Chronic Q fever*
•Vaccinated for Q fever
•Pregnancy;Cleared acute Q fever without residual symptoms:
•Use of immunosuppressant drugs during an acute Q fever infection or in the past 3 months
•Chronic Q fever patients, according to the national consensus *Chronic Q fever* [RIVM, Q-koortsvermoeidheidssyndroom]
•Vaccinated for Q fever
•QFS or CFS
•Evident somatic or psychiatric morbidity
•Pregnancy ;Healthy serologic negative volunteers:
•Use of immunosuppressant drugs in the past 3 months
•History of Q fever
•Chronic Q fever patients, according to the national consensus *Chronische Q-koorts*
•Vaccinated for Q fever
•QFS or CFS
•Evident somatic or psychiatric morbidity
•Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measures:<br /><br>•Cytokine concentrations (IL-6, IL-8, IL-10, IFN-γ and TNF-a)<br /><br>•Epigenetic changes in the different groups of patients (histone modification<br /><br>H3K4me3).<br /><br>•Transcriptome analysis<br /><br><br /><br>Cytokine concentrations will be measured with ELISA kits while epigenetic<br /><br>changes will be measured with chromatine immunoprecipitation. Transcriptome<br /><br>analysis will be conducted through RNA sequencing and biostatic pathway<br /><br>analysis. </p><br>

Secondary Outcome Measures