Clinical trial · Observational
Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection
Occurrence of Antibodies Cross-reacting With Autoantigens in Primary EBV Infection - a Longitudinal, Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epstein-Barr Virus (EBV) Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data collection: blood samples (analysed for EBV serology, auto-antibody-testing/biobanking, RNA expression analyses, procalcitonin) | Other | — | UNRESOLVED |
| Data collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments) | Other | — | UNRESOLVED |
| Data collection: Patient reported outcome (Fatigue questionnaires) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with confirmed primary EBV infection
- description
- 40 patients with 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)
- interventionNames
- Other: Data collection: Participant characteristics (Illness course, complications of primary EBV infection and provided treatments)
- Other: Data collection: blood samples (analysed for EBV serology, auto-antibody-testing/biobanking, RNA expression analyses, procalcitonin)
- Other: Data collection: Patient reported outcome (Fatigue questionnaires)
- label
- control patients
- description
- 40 control patients (Clinical picture of upper respiratory tract infection (including but not limited to tonsillitis/pharyngitis, malaise, headache, cough, rhinitis, cervical node enlargement)) and/ or confirmed primary Cytomegalovirus (CMV) infection
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.)
References
Publications (0)
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