Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT00336505
Status:
COMPLETED
Last Update Posted:
2010-02-26
First Post:
2006-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C405499', 'term': 'cethromycin'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deiznhamer@advancedlifesciences.com', 'phone': '630-739-6744', 'title': 'David Eiznhamer, PhD, Executive Vice President, Clinical Development', 'organization': 'Advanced Life Sciences'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Reported adverse events were recorded for 30 days after the last dose of study drug for individual subjects.', 'description': 'The safety population was defined as all randomized and dosed subjects with at least one follow up safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally', 'otherNumAtRisk': 288, 'otherNumAffected': 55, 'seriousNumAtRisk': 288, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally', 'otherNumAtRisk': 291, 'otherNumAffected': 37, 'seriousNumAtRisk': 291, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Small cell lung cancer extensive stage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 288, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cures in the Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally'}, {'id': 'OG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally'}], 'classes': [{'title': 'Clinical Cures', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Failures', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminates', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5667', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '8.9', 'groupDescription': 'The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)'}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug.', 'description': 'Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent to Treat Population is defined as all subjects with a confirmed diagnosis of community acquired pneumonia who took at least one dose of study medication. Subjects without a radiologist-confirmed chest X-ray for pneumonia were not included in the efficacy populations.'}, {'type': 'SECONDARY', 'title': 'Bacteriologic Cures in the Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally'}, {'id': 'OG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally'}], 'classes': [{'title': 'Bacteriologic Cures', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug.', 'description': 'All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all Intent to Treat subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.'}, {'type': 'PRIMARY', 'title': 'Clinical Cures in the Per Protocol Clinically Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '218', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally'}, {'id': 'OG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally'}], 'classes': [{'title': 'Clinical Cures', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Failures', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.9999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '5.1', 'groupDescription': 'The rate of clinical cure in each treatment group was calculated (number of cures/number of patient eligible for analysis). Non-inferiority will be demonstrated when the lower limit of the two-sided 95% confidence interval for the difference in the clinical cure rate at the Test-of-Cure visit between treatment groups (Cethromycin -Clarithromycin) is greater than delta, and includes zero, for both Per-Protocol (PP) and Intent-to-Treat (ITT) analyses.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Delta will be determined by the highest clinical cure-rate between the Cethromycin treatment group and the Clarithromycin treatment group, as follows: Greater than or equal to 90%, delta = -10%; Greater than or equal to 80% and less than 90%, delta = -15%, Greater than or equal to 70% and less than 80%, -20%)'}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug', 'description': 'Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Per Protocol Clinically Evaluable Population included all ITT subjects who took the protocol-defined minimum therapy duration, were dosed with no other antimicrobials (unless allowed by protocol), and had no other major protocol violations'}, {'type': 'SECONDARY', 'title': 'Bacteriologic Cures in the Per Protocol Clinically Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally'}, {'id': 'OG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally'}], 'classes': [{'title': 'Bacteriologic Cures', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug.', 'description': 'All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes all Per Protocol Clinically Evaluable subjects that were bacteriologically evaluable (ie., subjects with at least 1 evaluable pathogen) who showed eradication of all evaluable pathogens.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally'}, {'id': 'FG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All subjects who were randomized and dosed.', 'groupId': 'FG000', 'numSubjects': '291'}, {'comment': 'All subjects who were randomized and dosed.', 'groupId': 'FG001', 'numSubjects': '291'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of subjects completing the test of cure (TOC) visit.', 'groupId': 'FG000', 'numSubjects': '254'}, {'comment': 'Number of subjects completing the test of cure (TOC) visit.', 'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Subjects were recruited globally from January 2006 through October 2007.', 'preAssignmentDetails': 'In each treatment arm, one subject was enrolled and randomized to a blinded treatment but discontinued from study prior to administration of the first dose of drug. Thus, while official enrollment totalled 584 subjects, only 582 were randomized and dosed with blinded study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cethromycin', 'description': '300 mg once per day (QD) for 7 days, administered orally'}, {'id': 'BG001', 'title': 'Clarithromycin', 'description': '250 mg twice per day (BID) for 7 days, administered orally'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '14.5', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '16.3', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '15.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'All subjects who were randomized and dosed.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects who were randomized and dosed.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 584}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-29', 'studyFirstSubmitDate': '2006-06-09', 'resultsFirstSubmitDate': '2009-09-03', 'studyFirstSubmitQcDate': '2006-06-09', 'lastUpdatePostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-29', 'studyFirstPostDateStruct': {'date': '2006-06-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cures in the Intent to Treat Population', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug.', 'description': 'Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.'}, {'measure': 'Clinical Cures in the Per Protocol Clinically Evaluable Population', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug', 'description': 'Investigators evaluated subjects for a clinical response of cure, failure, or indeterminate. Cure: Improvement or return to preinfection state or lack of progression of all pulmonary infiltrates, and resolution of all signs/symptoms present at enrollment. Failure: Persistence or worsening of signs/symptoms, the need for additional antibiotic, new pulmonary infection, progression of the chest radiograph, or death due to pneumonia. Indeterminate: Evaluation was not possible (lost to follow up, adverse event, major protocol violation). Indeterminates default to failure for analysis.'}], 'secondaryOutcomes': [{'measure': 'Bacteriologic Cures in the Intent to Treat Population', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug.', 'description': 'All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).'}, {'measure': 'Bacteriologic Cures in the Per Protocol Clinically Evaluable Population', 'timeFrame': 'Test of Cure Visit, defined as 14-22 days after the first dose of study drug.', 'description': 'All bacteriologically evaluable subjects (ie., the subject had at least one, protocol-defined evaluable pathogen) who demonstrated eradication of all evaluable pathogens (S. pneumoniae, S. aureus, H. influenzae, M. catarrhalis, M. pneumoniae, C. pneumoniae, L. pneumophila).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pneumonia', 'Respiratory', 'Infection', 'Infectious', 'Advanced', 'Life', 'Sciences', 'Lung', 'Pulmonary', 'Cethromycin', 'Restanza', 'Clarithromycin', 'Biaxin'], 'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).', 'detailedDescription': 'Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ambulatory male or female, 18 years of age or older\n* If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)\n* Positive Chest X-ray consistent with diagnosis of bacterial pneumonia\n* Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact\n* Recent history of respiratory illness consistent with the clinical signs and symptoms of bacterial CAP\n* Must be able to produce sputum\n\nExclusion Criteria:\n\n* Prior hospitalization within previous 4 weeks\n* Residence at a chronic care facility\n* Active tuberculosis (or other mycobacterial infection, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic) involving the lung, bronchial obstruction, a history of post-obstructive pneumonia (chronic obstructive pulmonary disease \\[COPD\\] is not exclusionary), known or suspected Pneumocystis carinii pneumonia\n* Treatment with long-acting antimicrobial agents within the last 4 weeks, treatment with ceftriaxone, azithromycin or dirithromycin antibiotic within the last 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days prior to study drug administration\n* Any infection which requires the use of a concomitant antimicrobial agent\n* History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone, azalide or streptogramin antimicrobials\n* Treatment with another investigational drug within the last 4 weeks\n* Females who are pregnant or lactating\n* Subjects with known significant renal or hepatic impairment or disease\n* Subjects with a history of impaired renal function\n* Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied)\n* Subjects who would require parenteral antimicrobial therapy for the treatment of pneumonia\n* Any underlying disease or condition that would interfere with the completion of the study procedures and evaluations or absorption of the study drug\n* Currently receiving or are likely to require any of the following medications during the period between 2 weeks prior to Evaluation 1 and within 24 hours after the last dose of study drug: astemizol (Hismanal®) or pimozide (Orap®)\n* Currently receiving or are likely to require any of the following during the period from Evaluation 1 and within 24 hours after the last dose of study drug: theophylline or theophylline analogues (unless adequately monitored), carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John's Wort, lamotrigine, troglitazone, warfarin and digitalis glycoside. Other barbiturates may be used with careful monitoring\n* Subjects who are currently receiving or who are likely to require any of the following medications during the period between Evaluation 1 and 4: other systemic antibiotic therapy, rifampin or rifabutin\n* Immunocompromised subjects, subjects receiving immunosuppressive agents, subjects with known human immunodeficiency virus (HIV) infections and history of acquired immune deficiency syndrome (AIDS) defining conditions or CD4+ T-lymphocyte count \\<200.\n* Subject with known or suspected central nervous system (CNS) disorder that predisposes them to seizures/lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy)\n* Previous treatment with cethromycin\n* Subjects with signs of septic shock (e.g., mental confusion, severe hypoxemia, severe hypotension, any other condition requiring intensive care unit \\[ICU\\] admission)"}, 'identificationModule': {'nctId': 'NCT00336505', 'briefTitle': 'Study Comparing the Safety and Efficacy of Cethromycin to Clarithromycin for the Treatment of Community-Acquired Pneumonia (CAP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Life Sciences, Inc.'}, 'officialTitle': 'A Double-Blinded, Randomized, Parallel Group, Multi-Center, Multi-National Comparative Study of the Safety and Efficacy of Cethromycin 300 mg QD to Clarithromycin (BIAXIN® Filmtab®) 250 mg BID for the Treatment of Community-Acquired Pneumonia in Adults', 'orgStudyIdInfo': {'id': 'CL05-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clarithromycin', 'interventionNames': ['Drug: Clarithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'Cethromycin', 'interventionNames': ['Drug: Cethromycin']}], 'interventions': [{'name': 'Cethromycin', 'type': 'DRUG', 'otherNames': ['Restanza', 'ABT-773'], 'description': 'Cethromycin 300 mg once per day (QD) for 7 days, administered orally', 'armGroupLabels': ['Cethromycin']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'otherNames': ['Biaxin', 'Klacid', 'Klaracid'], 'description': 'Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally', 'armGroupLabels': ['Clarithromycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60517', 'city': 'Woodridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'CANADA - Advanced Life Sciences', 'geoPoint': {'lat': 41.74697, 'lon': -88.05034}}, {'zip': '60517', 'city': 'Woodridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'SOUTH AFRICA - Advanced Life Sciences', 'geoPoint': {'lat': 41.74697, 'lon': -88.05034}}, {'zip': '60517', 'city': 'Woodridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'USA - Advanced Life Sciences', 'geoPoint': {'lat': 41.74697, 'lon': -88.05034}}], 'overallOfficials': [{'name': 'David A. Eiznhamer, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Advanced Life Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Life Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'David Eiznhamer, PhD, Executive Vice President, Clinical Development', 'oldOrganization': 'Advanced Life Sciences'}}}}