Study on Infectious Mononucleosis in Munich

Epstein-Barr Virus Infections Clinical Trial

— IMMUC  

Official title:

Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002802
• Other study ID #: TTU 07.905/07.909
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2023
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Epstein-Barr Virus Infections
• Infections
• Infectious Mononucleosis

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

Germany, 

Outcome

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.

External Links

•   Federal Ministry of Education and Research
•   German Center for Infection Research