Investigating antibodies in primary Epstein-Barr virus infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the occurrence of antibodies that cross-react with autoantigens in patients experiencing primary Epstein-Barr virus (EBV) infection, compared to a control group. It will establish a biobank for longitudinal analysis of immune responses and inflammatory processes associated with EBV. Substudies will evaluate the effects of antibiotic treatment on primary EBV infection outcomes and measure procalcitonin levels in affected patients. The study focuses on understanding the relationship between EBV infection and the development of systemic autoimmune diseases.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants fulfilling all of the following inclusion criteria are eligible for the infectious mononucleosis (IM) group:

* Informed consent as documented by signature
* Confirmed primary EBV infection as confirmed by the treating clinician and defined by:
* 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)

AND

* 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).

Participants fulfilling all of the following inclusion criteria will be eligible for the control group:

* Informed consent as documented by signature.
* one of the following:

  1. Clinical picture of upper respiratory tract infection (including but not limited to tonsillitis/pharyngitis, malaise, headache, cough, rhinitis, cervical node enlargement)
  2. confirmed primary Cytomegalovirus (CMV) infection (an optimal control group; however, the number of patients with a diagnosis of primary CMV infection is limited).

Exclusion Criteria:

* 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.)

Where it's running

• University Hospital Basel, Division of Internal Medicine
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Michael Osthoff, PD Dr. med. — University Hospital Basel, Division of Internal Medicine
• Study coordinator: Michael Osthoff, PD Dr. med.
• Email: michael.osthoff@usb.ch
• Phone: +41 61 328 68 28

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.