Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03604705
Status:
COMPLETED
Last Update Posted:
2025-09-16
First Post:
2018-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marc.engelhardt@basilea.com', 'phone': '+41 79 701 0551', 'title': 'Study Director', 'organization': 'Basilea Pharmaceutica International Ltd, Allschwil'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'One to forty-nine days', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Population', 'description': 'Twenty-one patients were dosed with APX001 and composed the ITT/Safety Population.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'deathsNumAffected': 5, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterobacter sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotising fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stenotrophomonas sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Euthanasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Period - MITT', 'description': 'Treatment Success was defined as meeting all of the following criteria: 1) 2 consecutive blood cultures were negative for Candida spp.; 2) Alive at EOST; and 3) No concomitant use of any other systemic antifungal therapies through EOST. Treatment Failure is defined as any case that does not meet the criteria for Treatment Success.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One to forty-two days', 'description': 'Treatment Success is defined as meeting all of the following criteria:\n\nTwo consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to First Negative Blood Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MITT Population', 'description': 'MITT = Modified Intent-to-Treat population'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One to forty-nine days', 'description': 'Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-Baseline negative blood culture + 1. Patients without a negative blood culture at post-Baseline visits were censored at the last assessment date.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'EOST (End of Study Drug Treatment)', 'description': 'Eradication'}, {'id': 'OG001', 'title': 'EOT (End of Antifungal Treatment)', 'description': 'Eradication'}, {'id': 'OG002', 'title': 'Follow-up 2 Weeks After EOT', 'description': 'Recurrence'}, {'id': 'OG003', 'title': 'Follow-up 4 Weeks After EOT', 'description': 'Recurrence'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Success 2 Weeks After EOT', 'description': 'Treatment Success determined by the DRC by visit for the MITT Population.'}, {'id': 'OG001', 'title': 'Treatment Success 4 Weeks After EOT', 'description': 'Treatment success determined by the DRC by visit for the MITT Population.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}, {'value': '55.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 and 4 weeks after end of treatment (EOT)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival at Study Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MITT Population', 'description': 'MITT = Modified Intent-to-Treat population'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Twenty-one patients were dosed with APX001 and composed the ITT/Safety Population.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One to forty-nine days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'APX001 Treatment', 'description': 'APX001: APX001 IV administration followed by APX001 oral tablet administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Period - MITT', 'description': 'Evaluation of APX001 for the first-line treatment for candidemia, including suspected or confirmed antifungal-resistant candidemia, in non-neutropenic patients ≥ 18 years of age who had at least 1 positive blood culture within the 96 hours prior to starting study drug. Modified Intent-to-Treat (MITT) Population. The MITT Population contained 20 (95.2%) patients.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '19', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Treatment Period - MITT'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-03', 'size': 708437, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-21T15:06', 'hasProtocol': True}, {'date': '2020-04-27', 'size': 295703, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-21T15:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2018-07-19', 'resultsFirstSubmitDate': '2021-05-24', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-07-14', 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Success at End of Study Treatment (EOST) as Determined by the Data Review Committee (DRC)', 'timeFrame': 'One to forty-two days', 'description': 'Treatment Success is defined as meeting all of the following criteria:\n\nTwo consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment'}], 'secondaryOutcomes': [{'measure': 'Time to First Negative Blood Culture', 'timeFrame': 'One to forty-nine days', 'description': 'Time to first negative blood culture was defined as the number of days from first dose date of study drug to the date of first post-Baseline negative blood culture + 1. Patients without a negative blood culture at post-Baseline visits were censored at the last assessment date.'}, {'measure': 'Percentage of Patients With Mycological Outcomes at End of Study Treatment (EOST), End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)', 'timeFrame': 'End of study treatment (EOST), end of treatment (EOT), and 2 and 4 weeks after end of treatment (EOT)'}, {'measure': 'Percentage of Patients With Treatment Success at End of Treatment (EOT), and 2 and 4 Weeks After End of Treatment (EOT)', 'timeFrame': '2 and 4 weeks after end of treatment (EOT)'}, {'measure': 'Overall Survival at Study Day 30', 'timeFrame': 'Day 30'}, {'measure': 'Number of Patients With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'One to forty-nine days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Candidemia']}, 'referencesModule': {'references': [{'pmid': '37596890', 'type': 'RESULT', 'citation': 'Pappas PG, Vazquez JA, Oren I, Rahav G, Aoun M, Bulpa P, Ben-Ami R, Ferrer R, Mccarty T, Thompson GR, Schlamm H, Bien PA, Barbat SH, Wedel P, Oborska I, Tawadrous M, Hodges MR. Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial. J Antimicrob Chemother. 2023 Oct 3;78(10):2471-2480. doi: 10.1093/jac/dkad256.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older.\n\nSuspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks.\n\nThis study will be conducted at approximately 20 sites in the United States and globally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Provision of written consent\n* Adults ages 18 and above male or female\n* New diagnosis of candidemia\n* Able to have pre-existing intravascular catheters removed and replaced (as necessary)\n\nKey Exclusion Criteria:\n\n* neutropenia\n* deep-seated Candida-related infections\n* hepatosplenic candidiasis\n* received more than 2 days of prior systemic antifungal treatment for current candidemia episode\n* severe hepatic impairment'}, 'identificationModule': {'nctId': 'NCT03604705', 'briefTitle': 'An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non Neutropenic Patients With Candidemia, With or Without Invasive Candidiasis, Inclusive of Patients With Suspected Resistance to Standard of Care Antifungal Treatment', 'orgStudyIdInfo': {'id': 'APX001-201'}, 'secondaryIdInfos': [{'id': 'C4791009', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'APX001 Treatment', 'interventionNames': ['Drug: APX001']}], 'interventions': [{'name': 'APX001', 'type': 'DRUG', 'description': 'APX001', 'armGroupLabels': ['APX001 Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham School of Medicine', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham (UAB)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California-Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University (Georgia Regents University)', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas- Health Science Center and Medical School at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet,Service De Microbiologie', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universite Libre de Bruxelles (ULB) - Hopital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Lodelinsart', 'country': 'Belgium', 'facility': 'CHU de Charleroi - Hopital Civil Marie Curie', 'geoPoint': {'lat': 50.43138, 'lon': 4.44886}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Mont-Godinne University Hospital', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'University Hospital Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinik I fur Innere Medizin- Uniklinik Koln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - III. 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