The role of the immune system in Q Fever Fatigue Syndrome

The role of the immune system in Q Fever Fatigue Syndrome - QFS - Immunopathology

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42442

Enrollment

Registered

2015-06-02

Start date

2015-11-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coxiella burnetii Q fever

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results