Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT02202135
Status:
TERMINATED
Last Update Posted:
2017-09-06
First Post:
2014-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018461', 'term': 'Soft Tissue Infections'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097583', 'term': 'Ceftaroline'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D001398', 'term': 'Aztreonam'}], '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': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008997', 'term': 'Monobactams'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Yunxia.Lu@ppdi.com', 'phone': '910-558-4197', 'title': 'Yunxia Lu', 'organization': 'AstraZeneca-PPD'}, 'certainAgreement': {'otherDetails': 'The investigator agrees not to use such Confidential study information and not to disclose them to any other third parties, except that the undersigned shall not be prevented from using or disclosing information: (a) which by written records was previously known; (b) which is now public knowledge, (c) which is lawfully obtained by the undersigned from sources who have a lawful right to disclose such information.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small number of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of the first dose of study drug up to TOC visit (8 to 15 days after the last dose). Serious AEs were collected from time of signature of informed consent up to the LFU visit (21 to 35 days after the last dose).', 'eventGroups': [{'id': 'EG000', 'title': 'Ceftaroline', 'description': 'Ceftaroline fosamil 600 mg 120 min', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'notes': 'SAE started at 12:00 pm on and resolved at 13:00 pm on 2014-08-08. It was reported as important medical event which was assessed as moderate and unrelated to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Response at TOC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftaroline', 'description': 'Ceftaroline fosamil 600 mg 120 min'}], 'classes': [{'title': 'Clinical cure', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Clinical failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 to 20 days after last dose of study drug', 'description': 'Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \\>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \\>=8 days after the first dose.', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceftaroline', 'description': 'Ceftaroline fosamil 600 mg 120 min'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 4 patients were enrolled from 2 centres in 1 regions in this study. The first patient was enrolled on 15 September 2014 and the last patient last visit was on 02 January 2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ceftaroline', 'description': 'Ceftaroline fosamil 600 mg 120 min'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.25', 'spread': '4.875', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized patients'}}, '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': 4}}, 'statusModule': {'whyStopped': 'Overall study status is changed to "Terminated" due to low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2014-07-25', 'resultsFirstSubmitDate': '2015-12-18', 'studyFirstSubmitQcDate': '2014-07-25', 'lastUpdatePostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-02', 'studyFirstPostDateStruct': {'date': '2014-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Response at TOC', 'timeFrame': '7 to 20 days after last dose of study drug', 'description': 'Clinical cure is defined as resolution or improvement of signs and symptoms compared to baseline and no further antimicrobial therapy is necessary. Clinical failure is defined as any of the following: persistence or worsening in signs or symptoms, or requirement for concomitant antibiotic therapy, or requirement of an unplanned surgical intervention \\>48 hours after the first dose, or death caused by skin infection, or an AE leading to study drug discontinuation with alternative antimicrobial therapy required, or diagnosis of osteomyelitis \\>=8 days after the first dose.'}]}, 'conditionsModule': {'keywords': ['complicated skin and soft tissue infections (cSSTI)', 'skin infection', 'ceftaroline', 'wound infection', 'cellulitis', 'burn infection', 'bacterial infection', 'vancomycin'], 'conditions': ['Complicated Skin and Soft Tissue Infection']}, 'referencesModule': {'references': [{'pmid': '27585969', 'type': 'DERIVED', 'citation': 'Dryden M, Zhang Y, Wilson D, Iaconis JP, Gonzalez J. A Phase III, randomized, controlled, non-inferiority trial of ceftaroline fosamil 600 mg every 8 h versus vancomycin plus aztreonam in patients with complicated skin and soft tissue infection with systemic inflammatory response or underlying comorbidities. J Antimicrob Chemother. 2016 Dec;71(12):3575-3584. doi: 10.1093/jac/dkw333. Epub 2016 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.', 'detailedDescription': 'A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18 years or older - Complicated skin and skin structure infection (cSSTI) - Infection of sufficient severity to warrant hospitalization - Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose.\n\nExclusion Criteria:\n\n* Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug - Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens - Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease - Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb - Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock'}, 'identificationModule': {'nctId': 'NCT02202135', 'briefTitle': 'Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg Every 8 Hours) vs Vancomycin Plus Aztreonam in the Treatment of Patients With Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities.', 'orgStudyIdInfo': {'id': 'D3720C00001sub'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceftaroline fosamil', 'description': "Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function.", 'interventionNames': ['Drug: Ceftaroline fosamil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin plus aztreonam', 'description': "Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function", 'interventionNames': ['Drug: Vancomycin', 'Drug: Aztreonam']}], 'interventions': [{'name': 'Ceftaroline fosamil', 'type': 'DRUG', 'description': 'IV ceftaroline 600mg every 8 hours', 'armGroupLabels': ['Ceftaroline fosamil']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'IV vancomycin 15mg/kg every 12 hours', 'armGroupLabels': ['Vancomycin plus aztreonam']}, {'name': 'Aztreonam', 'type': 'DRUG', 'description': 'IV aztreonam 1 g every 8 hours', 'armGroupLabels': ['Vancomycin plus aztreonam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Research site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Research site', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Research site', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}, {'city': 'São José do Rio Preto', 'country': 'Brazil', 'facility': 'Research site', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Research site', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Temuco', 'country': 'Chile', 'facility': 'Research site', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}, {'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Research site', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Research site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Research site', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Research site', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Safed', 'country': 'Israel', 'facility': 'Research site', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Research site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Research site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Research site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Research site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Dundee', 'country': 'South Africa', 'facility': 'Research site', 'geoPoint': {'lat': -28.16678, 'lon': 30.23371}}, {'city': 'Worcester', 'country': 'South Africa', 'facility': 'Research site', 'geoPoint': {'lat': -33.64651, 'lon': 19.44852}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Research site', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Terrassa', 'country': 'Spain', 'facility': 'Research site', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Diyarbakır', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Research site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'David Melnick, MSD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}