Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-04 @ 5:04 PM
Study NCT ID:
NCT00645203
Status:
COMPLETED
Last Update Posted:
2008-03-27
First Post:
2008-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077525', 'term': 'Cefdinir'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 447}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'lastUpdateSubmitDate': '2008-03-20', 'studyFirstSubmitDate': '2008-03-20', 'studyFirstSubmitQcDate': '2008-03-20', 'lastUpdatePostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacteriological Response', 'timeFrame': '30 days'}, {'measure': 'Clinical response', 'timeFrame': '30 days'}, {'measure': 'Change in the otoscopic findings', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Physical exam; Vital signs; Use of concomitant medications', 'timeFrame': '59 days'}, {'measure': 'Adverse events assessment', 'timeFrame': '45 days with follow-up to a satisfactory conclusion'}, {'measure': 'Laboratory evaluations', 'timeFrame': '30 days'}]}, 'conditionsModule': {'conditions': ['Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female children between 6 months and 4 years of age\n* Weight does not exceed 40 kg\n* Clinical diagnosis is acute otitis media\n* Have evidence of middle ear fluid\n* At risk for persistent or recurrent otitis media\n* Generally in good health\n\nExclusion Criteria:\n\n* Sensitivity or allergy to penicillins or cephalosporins or inability to take oral medications\n* Presence of tympanostomy tubes, ventilation tube or perforated tympanic membrane, in either ear\n* Treatment with any anti-infective agent within 3 days prior to the study or treatment with a long-acting injectable antimicrobial agent (e.g. , penicillin G benzathine) within 4 weeks prior to the study\n* Concomitant infection, that requires additional antimicrobial therapy\n* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the patient's therapeutic response"}, 'identificationModule': {'nctId': 'NCT00645203', 'briefTitle': 'Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media', 'orgStudyIdInfo': {'id': 'M01-352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'interventionNames': ['Drug: cefdinir']}], 'interventions': [{'name': 'cefdinir', 'type': 'DRUG', 'otherNames': ['ABT-198, Omnicef, cefdinir'], 'description': 'cefdinir oral suspension, 25 mg/kg once daily for 10 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '93611', 'city': 'Clovis', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.82523, 'lon': -119.70292}}, {'zip': '93618', 'city': 'Dinuba', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.54328, 'lon': -119.38707}}, {'zip': '95630', 'city': 'Folsom', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.67796, 'lon': -121.17606}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '16508', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390-9035', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Providencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'city': 'Puente Alto, Santiago', 'country': 'Chile'}, {'city': 'Uruca', 'state': 'Provincia de San José', 'country': 'Costa Rica', 'geoPoint': {'lat': 9.94775, 'lon': -84.09576}}, {'city': 'San José', 'country': 'Costa Rica', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'zip': 'ZC 02', 'city': 'Santo Domingo', 'country': 'Dominican Republic', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'zip': '01011', 'city': 'Guatemala City', 'country': 'Guatemala', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'city': 'Guatemala City', 'country': 'Guatemala', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '4087', 'city': 'Panama City', 'country': 'Panama', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Angela M Nilius, Ph.D.', 'oldOrganization': 'Abbott'}}}}