Epstein-Barr Virus Infections Clinical Trial
— IMMUCOfficial title:
Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis
Verified date | August 2023 |
Source | Technical University of Munich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This observational clinical study aims at the identification of novel biomarkers and causative factors of complicated and/or protracted Epstein-Barr virus-associated infectious mononucleosis (IM). Clinical, biochemical, and routine virological data were collected from 200 patients with IM, novel analytical tools were implemented, and immunological and virological experimental data were generated using blood samples and mouthwashes. Patients have been investigated within four weeks after the onset of symptoms as well as one month and six months thereafter.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 39 Years |
Eligibility | Inclusion Criteria: - IM onset within the last four weeks - with at least one of four typical clinical findings (tonsillopharyngitis, fever, lymphadenopathy, fatigue) - virological findings indicating primary EBV infection (EBV-specific antibodies, EBV DNA). Exclusion Criteria: - Pregnancy - transfusion - and/or transplantation during the last year - and/or no informed consent. |
Country | Name | City | State |
---|---|---|---|
Germany | MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Technical University of Munich | German Cancer Research Center, German Center for Infection Research, Hannover Medical School, Helmholtz Zentrum München, Ludwig-Maximilians - University of Munich, University Hospital Freiburg |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity | Maximal severity of symptoms during the course of IM according the the IMMUC-Score. | Six months | |
Primary | Complexity | Maximal complexity of symptoms during the course of IM according the the IMMUC-Score | Six months | |
Primary | Protraction | Maximal protraction of symptoms during the course of IM according the the IMMUC-Score. | Six months | |
Secondary | Immune status | Cellular and humoral immune status, EBV viral load, antibodies against EBV proteome. | Within four weeks post symptom onset and at one and six months thereafter. |
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