Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-04-11 @ 3:11 PM
Study NCT ID:
NCT00593502
Status:
COMPLETED
Last Update Posted:
2009-06-19
First Post:
2008-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D010033', 'term': 'Otitis Media'}], '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'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053139', 'term': 'Oseltamivir'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-18', 'studyFirstSubmitDate': '2008-01-04', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication', 'timeFrame': '1-8 days'}], 'secondaryOutcomes': [{'measure': 'Time to resolution of fever and other clinical symptoms', 'timeFrame': '1-21 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['influenza', 'children', 'acute otitis media', 'oseltamivir'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '15378427', 'type': 'BACKGROUND', 'citation': 'Heikkinen T, Silvennoinen H, Peltola V, Ziegler T, Vainionpaa R, Vuorinen T, Kainulainen L, Puhakka T, Jartti T, Toikka P, Lehtinen P, Routi T, Juven T. Burden of influenza in children in the community. J Infect Dis. 2004 Oct 15;190(8):1369-73. doi: 10.1086/424527. Epub 2004 Sep 15.'}, {'pmid': '11224828', 'type': 'BACKGROUND', 'citation': 'Whitley RJ, Hayden FG, Reisinger KS, Young N, Dutkowski R, Ipe D, Mills RG, Ward P. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J. 2001 Feb;20(2):127-33. doi: 10.1097/00006454-200102000-00002.'}, {'pmid': '21106443', 'type': 'DERIVED', 'citation': 'Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa R, Ziegler T, Heikkinen T. Effectiveness of inactivated influenza vaccine in children aged 9 months to 3 years: an observational cohort study. Lancet Infect Dis. 2011 Jan;11(1):23-9. doi: 10.1016/S1473-3099(10)70255-3. Epub 2010 Nov 22.'}, {'pmid': '20815736', 'type': 'DERIVED', 'citation': 'Heinonen S, Silvennoinen H, Lehtinen P, Vainionpaa R, Vahlberg T, Ziegler T, Ikonen N, Puhakka T, Heikkinen T. Early oseltamivir treatment of influenza in children 1-3 years of age: a randomized controlled trial. Clin Infect Dis. 2010 Oct 15;51(8):887-94. doi: 10.1086/656408.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 1-3 years\n* Fever = or \\> 38.0 C and at least one respiratory symptom OR fever = or \\> 38.0 C and a positive influenza rapid test\n\nExclusion Criteria:\n\n* Confirmed infection with any other respiratory virus than influenza.\n* Suspicion of invasive bacterial infection requiring immediate admission to hospital\n* Evidence of a poorly controlled underlying medical condition\n* Known immunosuppression (malignancy, transplant, drugs)\n* Known allergy to oseltamivir or paracetamol\n* Received oseltamivir within 4 weeks\n* Participation in another clinical trial with an investigational drug'}, 'identificationModule': {'nctId': 'NCT00593502', 'acronym': 'ETOPOM', 'briefTitle': 'Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age', 'organization': {'class': 'OTHER', 'fullName': 'Hospital District of Southwestern Finland'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age', 'orgStudyIdInfo': {'id': 'MV21118'}, 'secondaryIdInfos': [{'id': 'EudraCT 2007-004734-17'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Oseltamivir', 'interventionNames': ['Drug: oseltamivir']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'oseltamivir', 'type': 'DRUG', 'otherNames': ['Tamiflu'], 'description': 'Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; \\> 40 kg, 75 mg twice daily, for 5 days', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'The dosage of placebo will be similar to the active drug', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Terho J Heikkinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital, Turku, Finland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital District of Southwestern Finland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Terho Heikkinen/Consulting Pediatrician, Assistant Professor', 'oldOrganization': 'Turku University Hospital, Turku, Finland'}}}}