Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-02 @ 12:43 PM
Study NCT ID:
NCT00638859
Status:
COMPLETED
Last Update Posted:
2009-10-02
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}]}, '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': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-01', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-18', 'lastUpdatePostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings'}], 'secondaryOutcomes': [{'measure': 'Clinical efficacy: change in the symptoms and signs'}, {'measure': 'Acceptability: compliance and willingness to take medication'}, {'measure': 'Pharmacokinetics: plasma concentrations of telithromycin'}]}, 'conditionsModule': {'keywords': ['Community-Acquired pneumonia', 'CAP', 'children', 'Child'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5-7 days in children with community-acquired pneumonia (CAP).\n\nSecondary objectives are to assess Pharmacokinetics, Efficacy and Acceptability of telithromycin 20 mg/kg qd for 5-7 days in children with CAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who are weighing 40 kg or less. If female, premenarchal status is required.\n* Subjects who are diagnosed with CAP based on chest X-ray showing the presence of a new infiltrate, clinical symptoms, and laboratory findings.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00638859', 'briefTitle': 'Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Evaluation of the Safety, Pharmacokinetics, Efficacy, and Acceptability of HMR3647 20 mg/kg qd for 5-7 Days With Community-Acquired Pneumonia (CAP) in Children (Multicenter, Open Label, Noncomparative Study)', 'orgStudyIdInfo': {'id': 'EFC6369'}, 'secondaryIdInfos': [{'id': 'HMR3647B/3101'}]}, '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': 'CSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}