Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT00315003
Status:
TERMINATED
Last Update Posted:
2009-04-03
First Post:
2006-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TELI COM - Telithromycin in Children With Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010035', 'term': 'Otitis Media, Suppurative'}, {'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D013492', 'term': 'Suppuration'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106791', 'term': 'telithromycin'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1500}}, 'statusModule': {'whyStopped': 'Pediatric development program terminated by sponsor', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-02', 'studyFirstSubmitDate': '2006-04-13', 'studyFirstSubmitQcDate': '2006-04-14', 'lastUpdatePostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary efficacy variables will be time to symptom resolution (TSR) and clinical cure at theposttherapy/TOC Visit 3.'}], 'secondaryOutcomes': [{'measure': 'Adverse events (AEs) reported by subjects, their parents/legally authorized representative, orobserved by the investigators will be recorded throughout the study.'}]}, 'conditionsModule': {'keywords': ['Otitis Media', 'Suppurative', 'Purulent', 'Ketolide', 'Azithromycin', 'Telithromycin', 'Controlled Clinical Trials'], 'conditions': ['Otitis Media, Suppurative', 'Otitis Media, Purulent']}, 'descriptionModule': {'briefSummary': 'This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \\<72 months \\[\\< 6 years of age\\]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects meeting all of the following criteria will be considered for enrollment into the study:\n\n* Subjects ≥6 months and \\<72 months (\\< 6 years) of age;\n* Recent (within the last 72 hours) and rapid onset of AOM symptoms and signs;\n* The presence of MEF on otoscopy indicated by a bulging tympanic membrane;\n* Otalgia or ear tugging or touching within the last 24 hours that interferes with or precludes normal activity or sleep;\n* At least 1 of the following clinical findings not specific to AOM: fever, vomiting, diarrhea, anorexia, sleep disturbance, or irritability;\n* Caregiver-reported AOM symptoms sufficient for entry according to protocol criteria.\n* Caregiver-reported AOM symptoms diary\n* Tympanometry exhibiting:\n\n * Type B curve or positive pressure peak curves.\n\nExclusion Criteria:\n\nSubjects presenting with any of the following will not be included in the study:\n\n* Uncertain diagnosis of AOM or mild to moderate symptoms and signs of AOM that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days.\n* Otorrhea or tympanostomy tube present in the ear to be evaluated;\n* Otitis externa;\n* Down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with \\<25% CD4 count or requiring prophylaxis for Pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection;\n* Known congenital long QT syndrome;\n* Known or suspected uncorrected hypokalemia (≤3 mmol/L \\[mEq/L\\]), hypomagnesemia, bradycardia (\\<50 bpm);\n* Myasthenia gravis;\n* Known impaired renal function, as shown by creatinine clearance ≤25 mL/min;\n* History of hypersensitivity or intolerance to macrolides or azithromycin;\n* Previous enrollment in this study or previous treatment with telithromycin;\n* Children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.'}, 'identificationModule': {'nctId': 'NCT00315003', 'briefTitle': 'TELI COM - Telithromycin in Children With Otitis Media', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 mg/kg od for 4 Days, in Children With Acute Otitis Media', 'orgStudyIdInfo': {'id': 'EFC6132'}, 'secondaryIdInfos': [{'id': 'HMR3647B/3002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Telithromycin', 'type': 'DRUG'}, {'name': 'Azithromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'zip': '1642', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '05677-000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Providencia', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'San José', 'country': 'Costa Rica', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'zip': '160 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}, {'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}, {'city': 'Israel', 'country': 'Israel', 'facility': 'Sanofi-Aventis'}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Lima', 'country': 'Peru', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'ICD CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}