Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT00768534
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2008-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Middle ear fluid and anasopharyngeal swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-05', 'studyFirstSubmitDate': '2008-10-07', 'studyFirstSubmitQcDate': '2008-10-07', 'lastUpdatePostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serotype distribution', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Otitis Media', 'Serotype distribution'], 'conditions': ['Otitis Media']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-4454&StudyName=Study%20Evaluating%20Microbiological%20Analysis%20of%20Spontaneous%20Draining%20Acute%20Otitis%20Media', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Years', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMain inclusion criteria:\n\n* Children \\>= 2 months and =\\< 5 years\n* Spontaneous draining AOM =\\< 2 days Main\n\nExclusion Criteria:\n\nexclusion criteria:\n\n* Previous operation of the ear\n* Chronic otitis media or tube placement with drainage \\>= 3 days\n* Chronic disease/immune deficiency'}, 'identificationModule': {'nctId': 'NCT00768534', 'briefTitle': 'Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates', 'orgStudyIdInfo': {'id': '0887X1-4454'}, 'secondaryIdInfos': [{'id': 'B1841014', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83684', 'city': 'Tegernsee', 'state': 'Bavarian', 'country': 'Germany', 'facility': 'Dr. Andreas Busse', 'geoPoint': {'lat': 47.7123, 'lon': 11.7582}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}