Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00932802
Status:
COMPLETED
Last Update Posted:
2012-11-19
First Post:
2009-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Greatest International Antiinfective Trial With Avelox
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-16', 'studyFirstSubmitDate': '2009-07-02', 'studyFirstSubmitQcDate': '2009-07-02', 'lastUpdatePostDateStruct': {'date': '2012-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice', 'timeFrame': 'During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).'}], 'secondaryOutcomes': [{'measure': 'Course of symptom relief', 'timeFrame': 'During documentation of up to two short-term follow-up visits (within ca. 14 days)'}, {'measure': 'Speed of return to normal daily life activities', 'timeFrame': 'During documentation of the last short-term follow-up visit (after ca. 14 days)'}, {'measure': 'Adverse events collection', 'timeFrame': 'Throughout the entire study, whenever Adverse Events occur'}, {'measure': 'Evaluation of frequency of new exacerbations', 'timeFrame': 'During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)'}, {'measure': 'Progression of chronic respiratory disease', 'timeFrame': 'During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non-Interventional', 'Observational', 'NIS', 'Moxifloxacin', 'MXF', 'Avelox', 'AECB'], 'conditions': ['Bronchitis, Chronic', 'Bronchial Diseases']}, 'referencesModule': {'references': [{'pmid': '22749710', 'type': 'RESULT', 'citation': 'Anzueto A, Miravitlles M, Ewig S, Legnani D, Heldner S, Stauch K. Identifying patients at risk of late recovery (>/= 8 days) from acute exacerbation of chronic bronchitis and COPD. Respir Med. 2012 Sep;106(9):1258-67. doi: 10.1016/j.rmed.2012.06.002. Epub 2012 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of AECB who take moxifloxacin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin\n\nExclusion Criteria:\n\n* Exclusion criteria must be read in conjunction with the local product information'}, 'identificationModule': {'nctId': 'NCT00932802', 'acronym': 'GIANT', 'briefTitle': 'Greatest International Antiinfective Trial With Avelox', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'GIANT - Greatest International Antiinfective Trial With Avelox®', 'orgStudyIdInfo': {'id': '12219'}, 'secondaryIdInfos': [{'id': 'AX0401', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '11828', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12206', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12214', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12234', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12213', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12212', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12216', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12220', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12219', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12217', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12225', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12223', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12229', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12221', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12218', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12222', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12230', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12211', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12227', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12228', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12226', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12235', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12233', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12224', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12215', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12231', 'type': 'OTHER', 'domain': 'Company Internal'}, {'id': '12232', 'type': 'OTHER', 'domain': 'Company Internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Moxifloxacin (Avelox, BAY12-8039)']}], 'interventions': [{'name': 'Moxifloxacin (Avelox, BAY12-8039)', 'type': 'DRUG', 'description': 'AECB patients under daily life treatment receiving moxifloxacin according to the local product information.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Austria'}, {'city': 'Many Locations', 'country': 'Brazil'}, {'city': 'Many Locations', 'country': 'China'}, {'city': 'Many Locations', 'country': 'Colombia'}, {'city': 'Many Locations', 'country': 'Croatia'}, {'city': 'Many Locations', 'country': 'Egypt'}, {'city': 'Many Locations', 'country': 'El Salvador'}, {'city': 'Many Locations', 'country': 'Germany'}, {'city': 'Many Locations', 'country': 'Hong Kong'}, {'city': 'Many Locations', 'country': 'Hungary'}, {'city': 'Many Locations', 'country': 'Indonesia'}, {'city': 'Many Locations', 'country': 'Malaysia'}, {'city': 'Many Locations', 'country': 'Mexico'}, {'city': 'Many Locations', 'country': 'Morocco'}, {'city': 'Many Locations', 'country': 'Netherlands'}, {'city': 'Many Locations', 'country': 'Pakistan'}, {'city': 'Many Locations', 'country': 'Philippines'}, {'city': 'Many Locations', 'country': 'Poland'}, {'city': 'Many Locations', 'country': 'Singapore'}, {'city': 'Many Locations', 'country': 'Slovenia'}, {'city': 'Many Locations', 'country': 'South Korea'}, {'city': 'Many Locations', 'country': 'Switzerland'}, {'city': 'Many Locations', 'country': 'Taiwan'}, {'city': 'Many Locations', 'country': 'Turkey (Türkiye)'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Bayer Schering Pharma AG', 'oldOrganization': 'Medical Affairs Therapeutic Area Head'}}}}