Actively Recruiting
Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection - a Longitudinal, Observational Study
Led by University Hospital, Basel, Switzerland · Updated on 2025-02-25
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the occurrence of antibodies that may cross-react with autoantigens linked to systemic lupus erythematosus (SLE) and other autoimmune diseases in people with primary Epstein-Barr Virus (EBV) infection. The study aims to create a biobank of these patients to analyze their immune response over time and explore inflammatory processes related to the infection. Additional substudies will examine antibiotic treatment outcomes, procalcitonin levels, and symptoms related to chronic fatigue syndrome after EBV infection. The study includes two groups: 40 patients diagnosed with primary EBV infection based on clinical symptoms and specific blood test results, and 40 control patients with similar respiratory symptoms or confirmed Cytomegalovirus infection. Researchers will collect participant characteristics, blood samples, and patient-reported fatigue questionnaires at several timepoints over 12 months. Blood samples will be analyzed for EBV serology, autoantibodies, RNA expression, and procalcitonin. Participants will be followed for one year with visits at baseline, 3 months, 6 months, and 12 months to monitor changes in antibodies, RNA expression, fatigue levels, and occurrence of complications like abscesses or tonsillectomy. Fatigue questionnaires will be completed at 6 and 12 months. The study will provide detailed longitudinal data on the immune response and symptoms after primary EBV infection to better understand its link with autoimmune responses and chronic fatigue.
CONDITIONS
Brief Title
Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Confirmed primary EBV infection by a doctor with symptoms like headache, fever, tonsillitis, and lab findings such as lymphocyte elevation
- Serology showing negative anti-EBNA IgG and positive anti-VCA IgM or similar combination
- For control group: informed consent and either symptoms of upper respiratory infection or confirmed primary Cytomegalovirus infection
You will not qualify if you...
- Suspicion or diagnosis of infectious mononucleosis in control group patients
- Immunosuppression including primary or secondary immunodeficiency or use of immunosuppressive drugs equivalent to 10mg prednisone or more
- History of autoimmune diseases like systemic lupus erythematosus or vasculitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline assessments including blood sample collection and evaluation of symptoms related to primary EBV infection or control conditions.
1 baseline visit (in-person)
Duration - 12 months
Participants are observed over 12 months to monitor the occurrence of antibodies cross-reacting with autoantigens and other immune responses, including fatigue questionnaires and illness course data collection.
Follow-up visits at 3, 6, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Division of Internal Medicine
Basel, Switzerland, 4031
Actively Recruiting
Research Team
M
Michael Osthoff, PD Dr. med.
S
Samuel Etienne
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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