Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Data collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments)

    Other intervention

    Data 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 intervention

    Data 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 intervention

    Data collection: Patient reported outcome (Fatigue questionnaires) at 6 and 12 months.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: patients with confirmed primary EBV infection3 interventions
Group B: control patients3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
at Visit 2 (day 1 (+ 1 day)), Visit 3 (3 months +/- 21 days), Visit 4 (6 months +/- 1 month) and Visit 5 (12 months +/-2 months)

Secondary outcomes

1

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.

Time frame
at Visit 2 (day 1 (+ 1 day)), Visit 3 (3 months +/- 21 days), Visit 4 (6 months +/- 1 month) and Visit 5 (12 months +/-2 months)
2

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.

Time frame
at month 6 and at month 12
3

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).

Time frame
at month 6 and at month 12
4

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

Time frame
on day 1 and day 3 (+/-1 day)

Other outcomes

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