Study on Infectious Mononucleosis in Munich

Completed

• Conditions: Infectious Mononucleosis; Epstein-Barr Virus Infections

• Registration Number: NCT06002802
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2023-08
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Protraction	Six months	Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.
Complexity	Six months	Maximal complexity of symptoms during the course of IM according the the IMMUC-Score
Severity	Six months	Maximal severity of symptoms during the course of IM according the the IMMUC-Score.

Secondary Outcome Measures

Name	Time	Method
Immune status	Within four weeks post symptom onset and at one and six months thereafter.	Cellular and humoral immune status, EBV viral load, antibodies against EBV proteome.

Trial Locations

Locations (1)

MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital; 🇩🇪 Munich, Bavaria, Germany