Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-04-12 @ 10:18 AM
Study NCT ID:
NCT02463669
Status:
TERMINATED
Last Update Posted:
2020-10-06
First Post:
2015-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007244', 'term': 'Infectious Mononucleosis'}, {'id': 'D013163', 'term': 'Splenomegaly'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'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': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID pandemic', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-04', 'studyFirstSubmitDate': '2015-05-31', 'studyFirstSubmitQcDate': '2015-06-03', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of splenomegaly (maximal splenic cranio-caudal length) on point-of-care ultrasound', 'timeFrame': '12 months', 'description': 'Splenomegaly is defined as a splenic length of \\> 11.5 centimetres (cm) for 10-12 year-old patients, \\> 12 cm for 12-15 year-old patients, \\> 12 cm for 15-35 year-old female patients, and \\> 13 cm for 15-35 year-old male patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Point-of-care ultrasound'], 'conditions': ['Infectious Mononucleosis', 'Splenomegaly']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if splenomegaly on point-of-care ultrasound (POCUS) is an accurate and user-friendly surrogate to the heterophile antibody test and Epstein-Barr Virus (EBV) serologies to diagnose acute mononucleosis infection in patients presenting with sore throat to the Emergency Department (ED).', 'detailedDescription': 'The investigators seek to determine whether the presence of splenomegaly on POCUS can accurately diagnose acute infectious mononucleosis in symptomatic ED patients, and determine the feasibility of performing point-of-care ultrasound for splenomegaly by emergency physicians in the emergency department setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample of patients between July 2016 and October 2017. Inclusion criteria are patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 10 and 35 year-old presenting to the ED with suspected acute infectious mononucleosis\n\nExclusion Criteria:\n\n* Chronic infectious disorders (eg. tuberculosis, malaria, HIV, syphilis)\n* Inflammatory disorders (eg. sarcoidosis, amyloidosis, systemic lupus erythematosus, Felty syndrome)\n* Proliferative disorders (eg. lymphoma, leukemia, essential thrombocytopenia, polycythemia vera)\n* Congestive disorders (eg: cirrhosis, portal hypertension, right heart failure, congenital heart disease)\n* Chronic haemolytic anemia (eg. sickle cell, thalassemia, hereditary spherocytosis)\n* Storage diseases (eg. Gaucher, Niemann-Pick)\n* Splenectomy\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT02463669', 'briefTitle': 'The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': 'The Use of Point-of-Care Ultrasound in the Diagnosis of Acute Infectious Mononucleosis in the Emergency Department', 'orgStudyIdInfo': {'id': 'POCUSIM01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Point-of-care ultrasound', 'type': 'DEVICE', 'description': 'Enrolled patients will undergo POCUS of the spleen by the treating emergency physician (resident, fellow or attending). Canadian Emergency Ultrasound Society (CEUS) certified residents, fellows and attending physicians will conduct the bedside ultrasonography after receiving specific training for the purposes of this study. The spleen will be assessed using a curved 2-6 Megahertz (MHz) transducer with the participant in the supine position. The cranio-caudal splenic length will be measured and its maximum dimension will be recorded on the standardized study data sheet.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1C4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Laurie Robichaud, MD', 'investigatorFullName': 'Laurie Robichaud', 'investigatorAffiliation': 'Jewish General Hospital'}}}}