Clinical trial NCT06002802: Study on Infectious Mononucleosis in Munich
Official title: Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Mononucleosis
Epstein-Barr Virus Infections
Keywords: EBV
Pfeiffer's glandular fever
Post-viral syndrome
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Helmholtz Zentrum München
name: German Cancer Research Center
name: Ludwig-Maximilians - University of Munich
name: Hannover Medical School
name: University Hospital Freiburg
name: German Center for Infection Research
First posted: 2023-08-21
Enrollment: 200
Sex: ALL
Minimum age (years): 0
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients with infectious mononucleosis.

Brief summary: 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.

Detailed description: EBV-associated diseases are a severe and global health problem, and novel tools and targets for a better pathogenetic understanding, diagnosis, treatment, and prevention are clearly needed. Here we propose to use several novel experimental approaches to investigate immunological, virological, biochemical, and clinical features in an observational study on Munich IM patients.

This study aims at identifying biomarkers and causative factors of protracted and/or complicated IM to facilitate the development of novel approaches to early diagnosis, therapy, and prevention of severe, life-threatening, and chronic EBV-associated diseases, including post-viral syndromes.

Two hundred patients with IM onset within the last four weeks were recruited from Munich health care institutions and were re-investigated at one and six months after the onset of symptoms. A novel diagnostic scoring system was developed to indicate the severity, complexity, and protraction of symptoms.

Investigated clinical parameters, including reported symptoms and physical signs of IM, as well as candidate risk factors in the medical history of patients and family members. Peripheral blood was analysed by established and novel analytical assays to determine the immunological and virological phenotypes of IM, and viral load was determined in mouthwashes.

Eligibility criteria: 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.

Primary outcomes:
measure: Severity
timeFrame: Six months
measure: Complexity
timeFrame: Six months
measure: Protraction
timeFrame: Six months
Secondary outcomes:
measure: Immune status
timeFrame: Within four weeks post symptom onset and at one and six months thereafter.
Other outcomes:
Locations:
city: Munich
country: Germany
facility: MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital
state: Bavaria
Study officials:
References: