Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-01 @ 4:26 PM
Study NCT ID:
NCT02561169
Status:
TERMINATED
Last Update Posted:
2017-08-04
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}, {'id': 'D002119', 'term': 'Calcium Carbonate'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D017610', 'term': 'Calcium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D008903', 'term': 'Minerals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-03', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-elective Hospitalizations (number of hospitalizations)', 'timeFrame': '28 days'}, {'measure': 'Length of non-elective hospitalization (days)', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': 'Lower respiratory tract infection (LRTI), (number of LRTIs)', 'timeFrame': '28 days'}, {'measure': 'Pneumonia (number of episodes of pneumonia)', 'timeFrame': '28 days'}, {'measure': 'Acute Sinusitis (number of episodes of acute sinusitis)', 'timeFrame': '28 Days'}, {'measure': 'New antimicrobial prescription (number of antimicrobial prescriptions)', 'timeFrame': '28 Days'}, {'measure': 'Medical visits for acute respiratory illness (number of medical visits)', 'timeFrame': '28 Days'}, {'measure': 'Death', 'timeFrame': '3 months'}, {'measure': 'Adverse Events (number of adverse events)', 'timeFrame': '5 days'}, {'measure': 'Admission to intensive or critical care unit (number of admissions)', 'timeFrame': '28 days'}, {'measure': 'Duration of stay in intensive or critical care unit (days)', 'timeFrame': '28 days'}, {'measure': 'Need for mechanical ventilation (number of mechanical ventilation)', 'timeFrame': '28 days'}, {'measure': 'Duration of mechanical ventilation (days)', 'timeFrame': '28 days'}]}, 'conditionsModule': {'keywords': ['antiviral', 'oseltamivir'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'A multi-centre, randomized, placebo controlled, trial. Participants will be patients either ≥65 years or with one or more high risk conditions presenting to one of four academic emergency departments in Edmonton or Calgary with influenza-like illness. The investigators will test for influenza using a point-of-care rapid test and if positive for influenza participants will be randomized to oseltamivir or placebo and followed prospectively. The primary outcome will be hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient at the University of Alberta Hospital, the Northeast Community Centre, Foothills Medical Centre, Rockyview General Hospital emergency departments\n* ≥ 18 years of age\n* ≥ 65 years of age OR chronic cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis, and asthma) , diabetes mellitus and other metabolic diseases, cancer, immunodeficiency, immunosuppression (due to underlying disease and/or therapy), renal disease, anemia, and hemoglobinopathy, any condition that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk of aspiration\n* Acute respiratory infection (ARI) exhibiting 2 or more symptoms, onset within last 72 hours\n* Laboratory confirmation of influenza infection, onset within last 72 hours\n\nExclusion Criteria:\n\n* Contraindication to oseltamivir (i.e., previous anaphylaxis)\n* Resident of a nursing home\n* Canadian Triage and Acuity Scale (CTAS) 1\n* Blood pressure \\< 90 mmHg\n* Respiratory rate \\>30 breaths per minute\n* PaO2 less \\<88%\n* Confusion\n* Inability to eat or drink\n* Radiographic evidence of pneumonia'}, 'identificationModule': {'nctId': 'NCT02561169', 'briefTitle': 'A Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'A Randomized Controlled Trial of Oseltamivir in High-Risk Patients Presenting to the Emergency Department With Influenza', 'orgStudyIdInfo': {'id': 'Oseltamivir - 2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oseltamivir', 'description': '75 mg oseltamivir orally twice daily for 5 days within 72 hours of symptom onset', 'interventionNames': ['Drug: Oseltamivir']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Oseltamivir', 'type': 'DRUG', 'otherNames': ['Tamiflu'], 'description': 'Those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. For patients with a known creatinine clearance \\< 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.', 'armGroupLabels': ['Oseltamivir']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Calcium Carbonate'], 'description': 'Those randomized to the control arm will receive 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir. For patients with a known creatinine clearance \\< 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4W4', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre Emergency Department', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Mark Loeb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}, {'name': 'University of Alberta', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}