IMMUC: Study on Infectious Mononucleosis in Munich

Sponsor

Technical University of Munich (Other)

Overall Status

Completed

CT.gov ID

NCT06002802

Collaborator

Helmholtz Munich, Munich (Other), German Cancer Research Center (Other), Ludwig-Maximilians-Universität, Munich (Other), Hannover Medical School, Hannover (Other), Albert-Ludwigs University Freiburg, Freiburg (Other), German Center for Infection Research (Other)

200

Enrollment

Location

Actual Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infectious Mononucleosis Epstein-Barr Virus Infections

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 Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Aug 31, 2020

Actual Study Completion Date :

Aug 31, 2020

Outcome Measures

Primary Outcome Measures

Severity [Six months]
Maximal severity 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
Protraction [Six months]
Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

IM onset within the last four weeks, with at least one of four typical clinical findings (tonsillopharyngitis, fever, lymphadenopathy, fatigue) and 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital	Munich	Bavaria	Germany	80804