Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2025-12-25 @ 11:54 AM
Study NCT ID:
NCT00717561
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2008-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects 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': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D017291', 'term': 'Clarithromycin'}], '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'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-02', 'studyFirstSubmitDate': '2008-07-16', 'studyFirstSubmitQcDate': '2008-07-16', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response 20 days after completion of study treatment (Test-of-Cure visit)', 'timeFrame': '20 days after last dose of study drug (TOC Visit)'}], 'secondaryOutcomes': [{'measure': 'Clinical and bacteriological response on the day of switch from IV to oral therapy', 'timeFrame': 'Day of switch from IV to oral therapy'}, {'measure': 'Clinical and bacteriological response on treatment Day 3-5 (if the day of switch is different from Day 3, 4 or 5)', 'timeFrame': 'Day 3-5'}, {'measure': 'Bacteriological response at TOC', 'timeFrame': '20 days after last dose of study drug'}, {'measure': 'Clinical and bacteriological response at the end of treatment', 'timeFrame': 'Day 7-14 after first dose of study drug'}, {'measure': 'Mortality attributable to pneumonia at the Test-of-Cure visit', 'timeFrame': '20 days after last dose of study drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CAP', 'Community-acquired pneumonia'], 'conditions': ['Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for information provided by EMA'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized non-ICU patients (age, \\>= 18 years)\n* Clinical signs and symptoms of CAP, with PSI score IV or V\n* Radiologically confirmed evidence of a new and/or progressive infiltrate(s)\n* Requirement for initial parenteral therapy\n* At least 2 of the following conditions:\n\n * Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum\n * Dyspnea and/or tachypnea (respiratory rate of \\> 20 breaths/min)\n * Rigors and/or chills\n * Pleuritic chest pain\n * Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation\n * Fever (an oral temperature of \\>= 38 °C, a rectal temperature of \\>= 39 °C, or a tympanic temperature of \\>= 38.5 °C) or hypothermia (rectal or core temperature of \\< 35 °C), and a WBC count of \\>= 10,000 cells/mm3 or \\>= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of \\< 4500 cells/mm3)\n* Written informed consent\n\nExclusion Criteria:\n\n* PSI Class I-III and V with need for ICU admission\n* Hospitalization for \\> 48 hours before developing pneumonia, or discharge from hospital \\< 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study'}, 'identificationModule': {'nctId': 'NCT00717561', 'briefTitle': 'A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia', 'orgStudyIdInfo': {'id': '12669'}, 'secondaryIdInfos': [{'id': '2007-001320-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Avelox (Moxifloxacin, BAY12-8039)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'interventionNames': ['Drug: Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin']}], 'interventions': [{'name': 'Avelox (Moxifloxacin, BAY12-8039)', 'type': 'DRUG', 'description': 'IV therapy: every 24 hours, patients will be administered a 400 mg moxifloxacin infusion over 60 minutes. Oral therapy: patients will be administered a single moxifloxacin 400 mg tablet, every 24 hours', 'armGroupLabels': ['Arm 1']}, {'name': 'Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin', 'type': 'DRUG', 'description': 'IV therapy: every 24 hours patients will be administered a 2 g ceftriaxone infusion over 30 minutes. Following the infusion with ceftriaxone, patients will be administered a 500 mg azithromycin infusion over 180 minutes.Oral therapy: every 8 hours patients will be administered a 1000 mg amoxicillin/clavulanic acid tablet. Every 12 hours patients will be administered a 500 mg clarithromycin tablet.', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87010', 'city': 'Lungro', 'state': 'Cosenza', 'country': 'Italy', 'geoPoint': {'lat': 39.73772, 'lon': 16.12586}}, {'zip': '73016', 'city': 'San Cesario di Lecce', 'state': 'Lecce', 'country': 'Italy', 'geoPoint': {'lat': 40.30221, 'lon': 18.16098}}, {'zip': '61034', 'city': 'Fossombrone', 'state': 'Pesaro e Urbino', 'country': 'Italy', 'geoPoint': {'lat': 43.69017, 'lon': 12.81173}}, {'zip': '84013', 'city': 'Pregiato Di Cava Dei Tirreni', 'state': 'Salerno', 'country': 'Italy'}, {'zip': '31029', 'city': 'Vittorio Veneto', 'state': 'Treviso', 'country': 'Italy', 'geoPoint': {'lat': 45.98026, 'lon': 12.30065}}, {'zip': '63100', 'city': 'Ascoli Piceno', 'country': 'Italy', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'zip': '82100', 'city': 'Benevento', 'country': 'Italy', 'geoPoint': {'lat': 41.1307, 'lon': 14.77816}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '95122', 'city': 'Catania', 'country': 'Italy', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '66100', 'city': 'Chieti', 'country': 'Italy', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}, {'zip': '71100', 'city': 'Foggia', 'country': 'Italy', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '55100', 'city': 'Lucca', 'country': 'Italy', 'geoPoint': {'lat': 43.84369, 'lon': 10.50447}}, {'zip': '62100', 'city': 'Macerata', 'country': 'Italy', 'geoPoint': {'lat': 43.29789, 'lon': 13.45293}}, {'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20142', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '00135', 'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00184', 'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '07100', 'city': 'Sassari', 'country': 'Italy', 'geoPoint': {'lat': 40.72586, 'lon': 8.55552}}, {'zip': '10154', 'city': 'Torino', 'country': 'Italy', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}