Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT01176058
Status:
TERMINATED
Last Update Posted:
2015-10-28
First Post:
2010-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058387', 'term': 'Candidemia'}], 'ancestors': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077612', 'term': 'Anidulafungin'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to small enrollment, the per-protocol population was not determined, and analysis was performed on the mITT population.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.", 'otherNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal obsturction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '62.50', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '71.43', 'groupId': 'OG001', 'lowerLimit': '38.0', 'upperLimit': '100.0'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '37.50', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '71.0'}, {'value': '28.57', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Intravenous Treatment (Up to Day 42)', 'description': 'Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available \\[N/A\\] for a participant with a successful clinical response).\n\nFailure - Any case that did not meet the criteria for success.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (MITT) population: participants had confirmed diagnosis of candidemia or other forms of invasive candidiasis, received at least 1 dose of study medication treatment, had at least 1 post-baseline efficacy evaluation. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Global Response at End of Treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '62.50', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '42.86', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '79.5'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '37.50', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '71.0'}, {'value': '57.14', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '93.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (Up to Day 42)', 'description': 'Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).\n\nFailure - Any case that did not meet the criteria for success.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data set to Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response at EOIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '100.0'}, {'value': '71.43', 'groupId': 'OG001', 'lowerLimit': '38.0', 'upperLimit': '100.0'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '55.0'}, {'value': '28.57', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '62.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Intravenous Treatment (Up to Day 42)', 'description': 'Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '100.0'}, {'value': '57.14', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '93.8'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '55.0'}, {'value': '42.86', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '79.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (Up to Day 42)', 'description': 'Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response at Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '100.0'}, {'value': '57.14', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '93.8'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '55.0'}, {'value': '42.86', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '79.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post treatment follow-up visit (Up to Day 52)', 'description': 'Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing data set to Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Response at EOIT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '100.0'}, {'value': '85.71', 'groupId': 'OG001', 'lowerLimit': '59.8', 'upperLimit': '100.0'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '55.0'}, {'value': '14.29', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '40.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Intravenous Treatment (Up to Day 42)', 'description': 'Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Response at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '100.0'}, {'value': '57.14', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '93.8'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '25.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '55.0'}, {'value': '42.86', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '79.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (Up to Day 42)', 'description': 'Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Response at Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '62.50', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '96.0'}, {'value': '57.14', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '93.8'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '37.50', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '71.0'}, {'value': '42.86', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '79.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post treatment follow-up visit (Up to Day 52)', 'description': 'Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population. N=number of participants with evaluable data; participants with missing or indeterminate data are set to Failure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'OG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Day 52', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All participants who have received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'FG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Insufficient mycological response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anidulafungin', 'description': 'Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.'}, {'id': 'BG001', 'title': 'Fluconazole', 'description': "IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 44 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Between 45 and 64 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'More than 65 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of Signs and Symptoms of Candidemia', 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Hypothermia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Tachycardia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White blood cell count decreased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White blood cell count increased', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White blood cell morphology abnormal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Respiratory rate increased', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Partial pressure of carbon dioxide (PCO2) decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mechanical ventilation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Feeling hot', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Localized erythema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Purulence', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Each participant could have been counted in more than 1 category for the signs and symptoms of Candidemia.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2010-08-03', 'resultsFirstSubmitDate': '2012-10-29', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-18', 'studyFirstPostDateStruct': {'date': '2010-08-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Global Response at End of Intravenous Treatment (EOIT)', 'timeFrame': 'End of Intravenous Treatment (Up to Day 42)', 'description': 'Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were not available \\[N/A\\] for a participant with a successful clinical response).\n\nFailure - Any case that did not meet the criteria for success.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Global Response at End of Treatment (EOT)', 'timeFrame': 'End of Treatment (Up to Day 42)', 'description': 'Global response included clinical and microbiological success or failure. Success - clinical success (defined as the resolution or significant improvement in signs and symptoms of invasive candidiasis) and microbiological success (defined as the eradication of Candida species present at baseline, as determined on follow-up culture, or the presumed eradication, if culture data were N/A for a participant with a successful clinical response).\n\nFailure - Any case that did not meet the criteria for success.'}, {'measure': 'Percentage of Participants With Clinical Response at EOIT', 'timeFrame': 'End of Intravenous Treatment (Up to Day 42)', 'description': 'Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.'}, {'measure': 'Percentage of Participants With Clinical Response at EOT', 'timeFrame': 'End of Treatment (Up to Day 42)', 'description': 'Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.'}, {'measure': 'Percentage of Participants With Clinical Response at Follow-Up', 'timeFrame': 'Post treatment follow-up visit (Up to Day 52)', 'description': 'Clinical response included success and failure. Success included Cure (resolution of signs and symptoms of the Candida infection) and Improvement (significant, but incomplete resolution of signs and symptoms of Candida infection). Failure defined as No significant improvement in signs and symptoms or death due to Candida infection or circumstances prevented an evaluation from being made.'}, {'measure': 'Percentage of Participants With Microbiological Response at EOIT', 'timeFrame': 'End of Intravenous Treatment (Up to Day 42)', 'description': 'Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).'}, {'measure': 'Percentage of Participants With Microbiological Response at EOT', 'timeFrame': 'End of Treatment (Up to Day 42)', 'description': 'Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).'}, {'measure': 'Percentage of Participants With Microbiological Response at Follow-Up', 'timeFrame': 'Post treatment follow-up visit (Up to Day 52)', 'description': 'Microbiological Success implies Eradication: culture negative for all Candida species present at baseline (documented), or culture data N/A (presumed). Microbiological Failure implies (1) Persistence: baseline Candida species present in repeat cultures (documented), or culture data N/A (presumed); (2) Recurrence: baseline Candida species isolated following eradication (documented), or culture data N/A (presumed); or (3) Indeterminate: culture data N/A (loss to follow-up or death that was not due to candidiasis or candidemia).'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Baseline to Day 52'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 3b', 'Efficacy and Safety evaluation of Anidulafungin', 'ICC'], 'conditions': ['Candidemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8851023&StudyName=A%20%20Study%20Of%20The%20Efficacy%20And%20Safety%20Of%20Anidulafungin%20Vs.%20Fluconazole%20In%20The%20Treatment%20Of%20Patients%20With%20Candidemia%20And/Or%20Other%20Forms', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.', 'detailedDescription': 'To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of candidemia or invasive candidiasis.\n* Presence of one or more of signs and symptoms of acute fungal infection.\n\nExclusion Criteria:\n\n* Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.\n* Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.'}, 'identificationModule': {'nctId': 'NCT01176058', 'briefTitle': 'A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis', 'orgStudyIdInfo': {'id': 'A8851023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'open label', 'interventionNames': ['Drug: Anidulafungin/Fluconazole']}], 'interventions': [{'name': 'Anidulafungin/Fluconazole', 'type': 'DRUG', 'description': 'Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days', 'armGroupLabels': ['open label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '210002', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing General Hospital of Nanjing Military Command/Respiratory Department', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital, Hemotology Department', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310016', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital / Department of Infectious Disease', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200040', 'city': 'Shanghai', 'country': 'China', 'facility': 'Institute of Antibiotics, Hua Shan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}