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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06002802
Other study ID # TTU 07.905/07.909
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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