Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT01045902
Status:
COMPLETED
Last Update Posted:
2010-01-11
First Post:
2010-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011015', 'term': 'Pneumonia, Aspiration'}, {'id': 'D008169', 'term': 'Lung Abscess'}], 'ancestors': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'C035444', 'term': 'sultamicillin'}], '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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-08', 'studyFirstSubmitDate': '2010-01-08', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events occuring after first application of study medication up to the test of cure visit for non-serious adverse events', 'timeFrame': 'Up to 30 days after end of treatment with study medication for serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Clinical Response', 'timeFrame': 'Regulary doing i.v. treatment'}]}, 'conditionsModule': {'keywords': ['Pulmonary Abscess', 'Aspiration Pneumonia'], 'conditions': ['Pneumonia, Aspiration', 'Lung Abscess']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine the efficacy and safety of Moxifloxacin in comparison to Sulbactam/Ampicillin in the treatment of pulmonary abscesses and aspiration pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 18 years or above\n* The primary diagnosis is community or hospital acquired primary pulmonary abscess or aspiration pneumonia, requiring initial parenteral treatment\n\nExclusion Criteria:\n\n* Known hypersensitivity to fluoroquinolones and/or ß-lactams\n* Patients with mechanical ventilation lasting more than 48 hours prior to enrollment, with poststenotic pneumonia, infarction pneumonia, pulmonary tuberculosis, lung abscess/pneumonia with concomitant endocarditis'}, 'identificationModule': {'nctId': 'NCT01045902', 'briefTitle': 'BAY12-8039, iv/Oral Pulmonary Abscess/Aspiration Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Prospective, Multi-center, Randomized, Non-blind Trial to Assess the Efficacy and Safety of Moxifloxacin Versus Sulbactam/Ampicillin in the Treatment of Pulmonary Abscess and Aspiration Pneumonia', 'orgStudyIdInfo': {'id': '10381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Avelox (Moxifloxacin, BAY12-8039)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Sulbactam/Ampicillin']}], 'interventions': [{'name': 'Avelox (Moxifloxacin, BAY12-8039)', 'type': 'DRUG', 'description': 'Moxifloxacin, 400 mg iv, od, switch after 6 doses (6 days) to 400 mg Moxifloxacin oral, od', 'armGroupLabels': ['Arm 1']}, {'name': 'Sulbactam/Ampicillin', 'type': 'DRUG', 'description': 'Sulbactam/Ampicillin, 3 g iv, tid, switch after 18 doses (6 days) to 750 mg Sulbactam/Ampicillin oral, bid', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '90419', 'city': 'Nuremberg', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '14929', 'city': 'Treuenbrietzen', 'state': 'Brandenburg', 'country': 'Germany', 'geoPoint': {'lat': 52.09754, 'lon': 12.87258}}, {'zip': '60596', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '31134', 'city': 'Hildesheim', 'state': 'Lower Saxony', 'country': 'Germany', 'geoPoint': {'lat': 52.15077, 'lon': 9.95112}}, {'zip': '27356', 'city': 'Rotenburg (Wümme)', 'state': 'Lower Saxony', 'country': 'Germany', 'geoPoint': {'lat': 53.11032, 'lon': 9.4036}}, {'zip': '58515', 'city': 'Lüdenscheid', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.21977, 'lon': 7.6273}}, {'zip': '46045', 'city': 'Oberhausen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.47805, 'lon': 6.8625}}, {'zip': '33098', 'city': 'Paderborn', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}, {'zip': '04129', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39112', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14165', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Therapeutic Area Head', 'oldOrganization': 'Bayer HealthCare AG'}}}}