Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 6:57 AM
Study NCT ID:
NCT00408135
Status:
COMPLETED
Last Update Posted:
2009-04-03
First Post:
2006-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106791', 'term': 'telithromycin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-02', 'studyFirstSubmitDate': '2006-12-05', 'studyFirstSubmitQcDate': '2006-12-05', 'lastUpdatePostDateStruct': {'date': '2009-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).'}], 'secondaryOutcomes': [{'measure': 'Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit'}]}, 'conditionsModule': {'keywords': ['Respiratory Tract Infections', 'Skin Diseases', 'Sinusitis'], 'conditions': ['Infections', 'Child']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).\n\nSecondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients of weight from 7.0 kg.\n* For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings.\n* For dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings.\n* For otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings\n* For dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection'}, 'identificationModule': {'nctId': 'NCT00408135', 'briefTitle': 'Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections', 'orgStudyIdInfo': {'id': 'EFC6371'}, 'secondaryIdInfos': [{'id': 'HMR3647B/3104'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'telithromycin (HMR3647)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Sanofi-Aventis', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Norifumi Yamamoto', 'role': 'STUDY_DIRECTOR', 'affiliation': 'sanofi-aventis Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}