Study on Infectious Mononucleosis in Munich (IMMUC)
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| ClinicalTrials.gov Identifier: NCT06002802 |
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Recruitment Status :
Completed
First Posted : August 21, 2023
Last Update Posted : February 7, 2024
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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 |
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| Infectious Mononucleosis Epstein-Barr Virus Infections |
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 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 : | March 1, 2016 |
| Actual Primary Completion Date : | August 31, 2020 |
| Actual Study Completion Date : | August 31, 2020 |
- Severity [ Time Frame: Six months ]Maximal severity of symptoms during the course of IM according the the IMMUC-Score.
- Complexity [ Time Frame: Six months ]Maximal complexity of symptoms during the course of IM according the the IMMUC-Score
- Protraction [ Time Frame: Six months ]Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.
- 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.
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | 0 Years to 39 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06002802
| Germany | |
| MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital | |
| Munich, Bavaria, Germany, 80804 | |
| Responsible Party: | Technical University of Munich |
| ClinicalTrials.gov Identifier: | NCT06002802 |
| Other Study ID Numbers: |
TTU 07.905/07.909 |
| First Posted: | August 21, 2023 Key Record Dates |
| Last Update Posted: | February 7, 2024 |
| Last Verified: | August 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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EBV Pfeiffer's glandular fever Post-viral syndrome |
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Communicable Diseases Infections Epstein-Barr Virus Infections Infectious Mononucleosis Virus Diseases Disease Attributes Pathologic Processes Herpesviridae Infections |
DNA Virus Infections Tumor Virus Infections Leukocyte Disorders Hematologic Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |