About this trial
The aim of this study is to assess the occurrence of antibodies cross-reacting with autoantigens that have been detected in the context of SLE in patients with primary EBV infection over time compared to a control group. It is to establish a biobank of patients with primary EBV infection allowing to longitudinally analyze the immune response and its accompanying inflammatory processes with focus on the occurrence of antibodies cross-reacting with autoantigens associated with SLE and other autoimmune diseases.
Substudies will analyze
* characteristics of primary EBV infection patients treated with antibiotics in comparison to patients treated without antibiotics and outcomes of these treatment regimens (occurrence of acute complications such as peritonsillar abscess (PTA) or need for tonsillectomy, frequency of fatigue or symptoms associated with chronic fatigue syndrome). * Procalcitonin (PCT) concentrations in primary EBV infection compared to control patients with similar symptoms and its association with disease severity and local complications. * the occurrence of fatigue and symptoms associated with chronic fatigue syndrome 6 and 12 months after primary EBV infection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Informed consent as documented by signature
Compatible clinical (infectious mononucleosis symptoms including but not limited to malaise, headache, fever, tonsillitis, pharyngitis, cervical lymph nodes enlargement) and laboratory picture (lymphocyte count elevation, LUC cells, reactive lymphocytes in manual differential, elevated liver enzymes; of note, not all typically described features have to be fulfilled)
serology compatible with primary EBV infection (anti-EBNA IgG negative, anti-VCA IgG negative, anti-VCA IgM positive OR anti-EBNA IgG negative, anti-VCA IgG positive, anti- VCA IgM positive).
Informed consent as documented by signature.
Disqualifiers
Suspicion/diagnosis of IM as per judgement of the treating clinician (control group only); this individual may be eligible later for the IM group if primary EBV infection is confirmed, subsequently.
Immunosuppression (broadly defined as primary/secondary immunodeficiency or treatment with an immunosuppressive medication including ≥ 10mg prednisone equivalent).
History of autoimmune disease (e.g. SLE, vasculitis etc.)
Trial population
Inpatients and outpatients with symptoms of infectious mononucleosis (IM) or a sore throat who are treated at the University Hospital of Basel will be approached.
Trial design
Cohort
Prospective
Treatments tested in this trial
Data collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments)
Other interventionData collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments) during 12 months (baseline visit and follow-up visits at 3, 6 and 12 months).
Data collection: blood samples (analysed for EBV serology, auto-antibody-testing/biobanking, RNA expression analyses, procalcitonin)
Other interventionData collection: blood samples (analysed for EBV serology, auto-antibody-testing/biobanking, RNA expression analyses, procalcitonin) during 12 months (baseline visit and follow-up visits at 3, 6 and 12 months).
Data collection: Patient reported outcome (Fatigue questionnaires)
Other interventionData collection: Patient reported outcome (Fatigue questionnaires) at 6 and 12 months.
Treatment groups
Trial outcomes
Primary outcomes
Change in occurrence of antibodies cross-reacting with autoantigens in patients with primary EBV infection
Change in occurrence of antibodies cross-reacting with autoantigens in patients with primary EBV infection compared to a control group.
Secondary outcomes
Change in RNA expression profiles of peripheral blood cells
Change in RNA expression profiles of peripheral blood cells in patients with primary EBV infection over time and compared to a control group.
Change in Fatigue Assessment Scale (FAS)
The total score ranges from 10 to 50. A total FAS score \< 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire
FACIT-F is a 13-item instrument designed to assess fatigue/ tiredness and its impact on daily activities and functioning in a number of chronic diseases. The instrument includes items such as tiredness, weakness, listlessness, lack of energy, and the impact of these feelings on daily functioning (e.g., sleeping, and social activities). Items are scored on a 0 - 4 response scale with anchors ranging from "Not at all" to "Very much so" (in which higher scores represent better functioning or less fatigue).
Change in Procalcitonin (PCT) (Substudy Procalcitonin)
Change in PCT compared in primary EBV infection patients with different disease severities and different treatment modalities (in particular if they received antibiotics or not), and in comparison to a control group (with mostly (viral) upper respiratory tract infection or primary CMV infection); In IM and control patients admitted to hospital, blood will be collected for PCT measurement
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