Viewing Study NCT00621504

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Ignite Creation Date: 2025-12-24 @ 9:22 PM
Ignite Modification Date: 2026-01-04 @ 3:40 PM
Study NCT ID: NCT00621504
Status: COMPLETED
Last Update Posted: 2017-03-14
First Post: 2008-02-11
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Moldova', 'Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097583', 'term': 'Ceftaroline'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'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': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cerexa.com', 'phone': '(510) 285-9200', 'title': 'Vice President, Clinical Sciences', 'organization': 'Cerexa, Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Safety analysis was performed on the Safety Population, consisting of any subject who received any amount of actual study drug', 'eventGroups': [{'id': 'EG000', 'title': 'Ceftaroline Fosamil for Injection', 'description': 'Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)', 'otherNumAtRisk': 298, 'otherNumAffected': 65, 'seriousNumAtRisk': 298, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'IV Ceftriaxone', 'description': 'Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).', 'otherNumAtRisk': 308, 'otherNumAffected': 53, 'seriousNumAtRisk': 308, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastrointestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Multiorgan disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Small cell lung cancer, state unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Lung adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Thrombotic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'Ischemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 298, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftaroline Fosamil for Injection', 'description': 'Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)'}, {'id': 'OG001', 'title': 'IV Ceftriaxone', 'description': 'Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).'}], 'classes': [{'title': 'Clinical Cure', 'categories': [{'measurements': [{'value': '244', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Failure', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '12.6', 'estimateComment': 'Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.', 'groupDescription': 'The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared to that for ceftriaxone at TOC in the CE and MITTE Populations in adult subjects with CABP.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on each of the CE and the MITTE Populations at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for each of the CE and MITTE Populations.'}], 'paramType': 'NUMBER', 'timeFrame': '8 to 15 days after last dose of study drug', 'description': 'Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary\n\nFailure: Any of the following:\n\n* Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy\n* Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia\n* Death wherein pneumonia (ie,CABP) was considered causative\n\nIndeterminate: Inability to determine an outcome', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.'}, {'type': 'SECONDARY', 'title': 'Clinical Response at End of Therapy (EOT)', 'timeFrame': 'Last day of study drug administration', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Microbiological Success Rate at Test of Cure (TOC)', 'timeFrame': '8-15 days after last dose of study drug', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)', 'timeFrame': '8-15 days after last day of study drug', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Clinical and Microbiological Response by Pathogen at TOC', 'timeFrame': '8-15 days after last dose of study drug', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Clinical Relapse at Late Follow Up (LFU)', 'timeFrame': '21-35 days after last dose of study drug', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population', 'timeFrame': '8-15 days after last dose of study drug', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Microbiological Re-infection/Recurrence at LFU', 'timeFrame': '21 to 35 days after last dose of study drug', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Evaluate Safety', 'timeFrame': 'first dose, throughout the treatment period, and up to the TOC visit', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceftaroline Fosamil for Injection', 'description': 'Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)'}, {'id': 'FG001', 'title': 'IV Ceftriaxone', 'description': 'Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '307'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '273'}, {'groupId': 'FG001', 'numSubjects': '282'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'At the request of sponsor/investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'The enrollment period was from 02 January 2008 to 29 December 2008', 'preAssignmentDetails': 'Patients were screened for up to 24 hours'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '606', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ceftaroline Fosamil for Injection', 'description': 'Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)'}, {'id': 'BG001', 'title': 'IV Ceftriaxone', 'description': 'Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '311', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '16.6', 'groupId': 'BG001'}, {'value': '61.0', 'spread': '16.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Non-Hispanic', 'categories': [{'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '280', 'groupId': 'BG001'}, {'value': '550', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2008-02-11', 'resultsFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-10-12', 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure Rate at Test-of-Cure (TOC) in the Modified Intent-to-Treat Efficacy (MITTE) Populations', 'timeFrame': '8 to 15 days after last dose of study drug', 'description': 'Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary\n\nFailure: Any of the following:\n\n* Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy\n* Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia\n* Death wherein pneumonia (ie,CABP) was considered causative\n\nIndeterminate: Inability to determine an outcome'}, {'measure': 'Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at Test-of-Cure (TOC) in the Clinically Evaluable (CE) Population', 'timeFrame': '8-15 days after last dose of study drug'}], 'secondaryOutcomes': [{'measure': 'Clinical Response at End of Therapy (EOT)', 'timeFrame': 'Last day of study drug administration'}, {'measure': 'Microbiological Success Rate at Test of Cure (TOC)', 'timeFrame': '8-15 days after last dose of study drug'}, {'measure': 'Overall (Clinical and Radiographic) Success Rate at Test of Cure (TOC)', 'timeFrame': '8-15 days after last day of study drug'}, {'measure': 'Clinical and Microbiological Response by Pathogen at TOC', 'timeFrame': '8-15 days after last dose of study drug'}, {'measure': 'Clinical Relapse at Late Follow Up (LFU)', 'timeFrame': '21-35 days after last dose of study drug'}, {'measure': 'Microbiological Re-infection/Recurrence at LFU', 'timeFrame': '21 to 35 days after last dose of study drug'}, {'measure': 'Evaluate Safety', 'timeFrame': 'first dose, throughout the treatment period, and up to the TOC visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ceftaroline', 'Community-acquired pneumonia', 'CAP', 'IV (intravenous)', 'Streptococcus pneumoniae', 'Haemophilus influenzae', 'Mycoplasma pneumoniae', 'Chlamydophila spp', 'Legionella spp', 'Multi-drug resistant Streptococcus pneumoniae (MDRSP)', 'antimicrobial resistance', 'pneumococci', 'Ceftriaxone', 'bacteria', 'ß-lactam', 'beta-lactam', 'antibiotic'], 'conditions': ['Bacterial Pneumonia']}, 'referencesModule': {'references': [{'pmid': '34922058', 'type': 'DERIVED', 'citation': 'Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.'}, {'pmid': '30597021', 'type': 'DERIVED', 'citation': 'Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.'}, {'pmid': '26702925', 'type': 'DERIVED', 'citation': 'Taboada M, Melnick D, Iaconis JP, Sun F, Zhong NS, File TM, Llorens L, Friedland HD, Wilson D. Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials. J Antimicrob Chemother. 2016 Apr;71(4):862-70. doi: 10.1093/jac/dkv415. Epub 2015 Dec 24.'}, {'pmid': '25487791', 'type': 'DERIVED', 'citation': 'Lodise TP, Anzueto AR, Weber DJ, Shorr AF, Yang M, Smith A, Zhao Q, Huang X, File TM. Assessment of time to clinical response, a proxy for discharge readiness, among hospitalized patients with community-acquired pneumonia who received either ceftaroline fosamil or ceftriaxone in two phase III FOCUS trials. Antimicrob Agents Chemother. 2015 Feb;59(2):1119-26. doi: 10.1128/AAC.03643-14. Epub 2014 Dec 8.'}, {'pmid': '23357290', 'type': 'DERIVED', 'citation': 'Shorr AF, Kollef M, Eckburg PB, Llorens L, Friedland HD. Assessment of ceftaroline fosamil in the treatment of community-acquired bacterial pneumonia due to Streptococcus pneumoniae: insights from two randomized trials. Diagn Microbiol Infect Dis. 2013 Mar;75(3):298-303. doi: 10.1016/j.diagmicrobio.2012.12.002. Epub 2013 Jan 26.'}, {'pmid': '21482570', 'type': 'DERIVED', 'citation': 'Rank DR, Friedland HD, Laudano JB. Integrated safety summary of FOCUS 1 and FOCUS 2 trials: Phase III randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii53-9. doi: 10.1093/jac/dkr099.'}, {'pmid': '21482566', 'type': 'DERIVED', 'citation': 'File TM Jr, Low DE, Eckburg PB, Talbot GH, Friedland HD, Lee J, Llorens L, Critchley IA, Thye DA; FOCUS 1 investigators. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011 Apr;66 Suppl 3:iii19-32. doi: 10.1093/jac/dkr096.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia', 'detailedDescription': 'The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of Community-Acquired Pneumonia. Clinical trials for this study is held in many countries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects are required to meet the following inclusion criteria:\n\n* Community-acquired pneumonia\n* initial hospitalization, or treatment in an emergency room or urgent care setting\n* infection would require initial treatment with IV antimicrobials.\n\nExclusion Criteria:\n\nSubjects must NOT meet any of the following exclusion criteria:\n\n* CAP suitable for outpatient therapy with an oral antimicrobial agent\n* respiratory tract infections not due to community-acquired bacterial\n* Non-infectious causes of pulmonary infiltrates\n* Pleural empyema\n* Infection with an atypical organism\n* History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial\n* History of any hypersensitivity or allergic reaction to clarithromycin or any macrolide/ ketolide'}, 'identificationModule': {'nctId': 'NCT00621504', 'acronym': 'CAP', 'briefTitle': 'Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Ceftriaxone, With Adjunctive Clarithromycin, in the Treatment of Adult Subjects With Community-Acquired Pneumonia', 'orgStudyIdInfo': {'id': 'P903-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceftaroline fosamil for Injection', 'description': 'Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h).\n\nIn both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.', 'interventionNames': ['Drug: Ceftaroline fosamil for Injection', 'Drug: Clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Ceftriaxone', 'description': 'Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).\n\nIn both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.', 'interventionNames': ['Drug: IV Ceftriaxone', 'Drug: Placebo', 'Drug: Clarithromycin']}], 'interventions': [{'name': 'Ceftaroline fosamil for Injection', 'type': 'DRUG', 'description': '2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days', 'armGroupLabels': ['Ceftaroline fosamil for Injection']}, {'name': 'IV Ceftriaxone', 'type': 'DRUG', 'otherNames': ['Ceftriaxone'], 'description': '1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days', 'armGroupLabels': ['IV Ceftriaxone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind', 'armGroupLabels': ['IV Ceftriaxone']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'description': 'In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.', 'armGroupLabels': ['Ceftaroline fosamil for Injection', 'IV Ceftriaxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90015', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Investigational site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92114', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30905', 'city': 'Fort Gordon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 33.42097, 'lon': -82.16206}}, {'zip': '61603', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Investigational Site', 'geoPoint': {'lat': 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