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Completed

NCT Number: NCT06002802

Study on Infectious Mononucleosis in Munich

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.

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Key information

Age range

0 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Munich, Bavaria, 80804, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Severity

    Time frame: Six months

    Maximal severity of symptoms during the course of IM according the the IMMUC-Score.

  2. Complexity

    Time frame: Six months

    Maximal complexity of symptoms during the course of IM according the the IMMUC-Score

  3. Protraction

    Time frame: Six months

    Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.

Secondary outcomes

  1. Immune status

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Collaborators

  • German Cancer Research Center
  • German Center for Infection Research
  • Hannover Medical School
  • Helmholtz Zentrum München
  • Ludwig-Maximilians - University of Munich
  • University Hospital Freiburg

Registry information

Official study title

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

Acronym: IMMUC

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2023
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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