Study on Infectious Mononucleosis in Munich
IMMUC
Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFirst Submitted
Initial submission to the registry
August 16, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedFebruary 7, 2024
August 1, 2023
4.5 years
August 16, 2023
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Severity
Maximal severity of symptoms during the course of IM according the the IMMUC-Score.
Six months
Complexity
Maximal complexity of symptoms during the course of IM according the the IMMUC-Score
Six months
Protraction
Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.
Six months
Secondary Outcomes (1)
Immune status
Within four weeks post symptom onset and at one and six months thereafter.
Eligibility Criteria
200 patients with infectious mononucleosis.
You may qualify if:
- 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).
You may not qualify if:
- Pregnancy
- transfusion
- and/or transplantation during the last year
- and/or no informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Technical University of Munichlead
- Helmholtz Zentrum Münchencollaborator
- German Cancer Research Centercollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- Hannover Medical Schoolcollaborator
- University Hospital Freiburgcollaborator
- German Center for Infection Researchcollaborator
Study Sites (1)
MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital
Munich, Bavaria, 80804, Germany
Related Links
Biospecimen
Blood, mouthwashes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2023
First Posted
August 21, 2023
Study Start
March 1, 2016
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
February 7, 2024
Record last verified: 2023-08