Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2025-12-26 @ 2:25 AM
Study NCT ID:
NCT06002802
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2023-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Infectious Mononucleosis in Munich
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007244', 'term': 'Infectious Mononucleosis'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood, mouthwashes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-08-16', 'studyFirstSubmitQcDate': '2023-08-16', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity', 'timeFrame': 'Six months', 'description': 'Maximal severity of symptoms during the course of IM according the the IMMUC-Score.'}, {'measure': 'Complexity', 'timeFrame': 'Six months', 'description': 'Maximal complexity of symptoms during the course of IM according the the IMMUC-Score'}, {'measure': 'Protraction', 'timeFrame': 'Six months', 'description': 'Maximal protraction of symptoms during the course of IM according the the IMMUC-Score.'}], 'secondaryOutcomes': [{'measure': 'Immune status', 'timeFrame': 'Within four weeks post symptom onset and at one and six months thereafter.', 'description': 'Cellular and humoral immune status, EBV viral load, antibodies against EBV proteome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EBV', "Pfeiffer's glandular fever", 'Post-viral syndrome'], 'conditions': ['Infectious Mononucleosis', 'Epstein-Barr Virus Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gesundheitsforschung-bmbf.de/de/epstein-barr-virus-von-harmlos-bis-folgenschwer-7238.php', 'label': 'Federal Ministry of Education and Research'}, {'url': 'https://www.dzif.de/en/epstein-barr-virus-harmless-severe-consequences', 'label': 'German Center for Infection Research'}]}, 'descriptionModule': {'briefSummary': '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).\n\nClinical, 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.', 'detailedDescription': '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.\n\nThis 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.\n\nTwo 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.\n\nInvestigated 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 patients with infectious mononucleosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* IM onset within the last four weeks\n* with at least one of four typical clinical findings (tonsillopharyngitis, fever, lymphadenopathy, fatigue) - virological findings indicating primary EBV infection (EBV-specific antibodies, EBV DNA).\n\nExclusion Criteria:\n\n* Pregnancy\n* transfusion\n* and/or transplantation during the last year\n* and/or no informed consent.'}, 'identificationModule': {'nctId': 'NCT06002802', 'acronym': 'IMMUC', 'briefTitle': 'Study on Infectious Mononucleosis in Munich', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Study on Biomarkers and Causative Factors of Complicated and/or Protracted Epstein-Barr Virus-associated Infectious Mononucleosis', 'orgStudyIdInfo': {'id': 'TTU 07.905/07.909'}}, 'contactsLocationsModule': {'locations': [{'zip': '80804', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': "MRI Chonic Fatigue Center for Young People (MCFC), Children's Hospital, Technical University of Munich & Munich Municipal Hospital", 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helmholtz Zentrum München', 'class': 'INDUSTRY'}, {'name': 'German Cancer Research Center', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Hannover Medical School', 'class': 'OTHER'}, {'name': 'University Hospital Freiburg', 'class': 'OTHER'}, {'name': 'German Center for Infection Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}