Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05065658
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients
Sponsor:
Organization:
Raw JSON
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On average 20 days', 'description': 'Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not', 'unitOfMeasure': 'Cases per 1000 ICU days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk Factors for CAPA Development (EORTC/MSGERC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)', 'description': 'Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment'}, {'id': 'OG001', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)', 'description': 'Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment'}, {'id': 'OG002', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)', 'description': 'Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'ICU admission to ICU discharge. On average 20 days', 'description': 'This Outcome Measure examines whether the presence of an EORTC/MSGERC-defined risk factor at ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge.\n\nFor this purpose, the number of subjects who had underlying EORTC/MSGERC risk factors present at ICU admission was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Risk Factors for CAPA Development (ECMO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)', 'description': 'Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment'}, {'id': 'OG001', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)', 'description': 'Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment'}, {'id': 'OG002', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)', 'description': 'Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'ICU admission to ICU discharge. On average 20 days', 'description': 'This Outcome Measure examines whether the need for extracorporal membrange oxygenation (ECMO) treatment during ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge.\n\nFor this purpose, the number of subjects who required ECMO treatment during ICU stay was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)', 'description': 'Cases: Intravenous posaconazole prophylaxis'}, {'id': 'FG001', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)', 'description': 'Controls: Standard of care (no antifungal prophylaxis)'}, {'id': 'FG002', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)', 'description': 'Controls: Standard of care (no antifungal prophylaxis)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '83'}, {'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'COVID-19 Patients With Acute Respiratory Failure Receiving Posaconazole Prophylaxis (Center 1)', 'description': 'Cases: Subjects with COVID-19 associated ARF who received intravenous posaconazole prophylaxis upon ICU admission in addition to standard of care treatment'}, {'id': 'BG001', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 2)', 'description': 'Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment'}, {'id': 'BG002', 'title': 'COVID-19 Patients With Acute Respiratory Failure Without Antifungal Prophylaxis (Center 3)', 'description': 'Controls: Subjects with COVID-19 associated ARF who did not receive antifungal prophylaxis in addition to standard of care treatment'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000', 'lowerLimit': '58', 'upperLimit': '71'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '72'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '71'}, {'value': '65', 'groupId': 'BG003', 'lowerLimit': '58', 'upperLimit': '71'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race data were not collected', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Race data were not collected'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'categories': [{'measurements': 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{'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Systemic glucocorticoid treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-05', 'size': 855901, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-05T04:29', 'hasProtocol': True}, {'date': '2023-09-24', 'size': 1730043, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-07T07:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2021-09-09', 'resultsFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2021-09-22', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-30', 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)', 'timeFrame': 'ICU admission to ICU discharge. On average 20 days', 'description': 'Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not'}], 'secondaryOutcomes': [{'measure': 'Risk Factors for CAPA Development (EORTC/MSGERC)', 'timeFrame': 'ICU admission to ICU discharge. On average 20 days', 'description': 'This Outcome Measure examines whether the presence of an EORTC/MSGERC-defined risk factor at ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge.\n\nFor this purpose, the number of subjects who had underlying EORTC/MSGERC risk factors present at ICU admission was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.'}, {'measure': 'Risk Factors for CAPA Development (ECMO)', 'timeFrame': 'ICU admission to ICU discharge. On average 20 days', 'description': 'This Outcome Measure examines whether the need for extracorporal membrange oxygenation (ECMO) treatment during ICU admission is associated with an increased risk of developing COVID-19-associated pulmonary aspergillosis (CAPA) during the ICU stay. The analysis is conducted using a cohort of patients admitted to the ICU, tracking the development of CAPA from ICU admission to ICU discharge.\n\nFor this purpose, the number of subjects who required ECMO treatment during ICU stay was collected and used as a parameter in a multivariate logistic model to assess the association with an increased risk for CAPA development.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Respiratory Infection', 'Aspergillosis']}, 'referencesModule': {'references': [{'pmid': '39800852', 'type': 'DERIVED', 'citation': 'Prattes J, Giacobbe DR, Marelli C, Signori A, Dettori S, Cattardico G, Hatzl S, Reisinger AC, Eller P, Krause R, Reizine F, Bassetti M, Gangneux JP, Hoenigl M. Posaconazole for Prevention of COVID-19-Associated Pulmonary Aspergillosis in Mechanically Ventilated Patients: A European Multicentre Case-Control Study (POSACOVID). Mycoses. 2025 Jan;68(1):e70023. doi: 10.1111/myc.70023.'}]}, 'descriptionModule': {'briefSummary': 'COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be comprised of patients admitted to the ICU because of severe SARS-CoV-2 infections, who are requiring mechanical ventilation and receive dexamethasone as part of their COVID-19 ARDS treatment in medical centers in i) Graz, Austria (cases), and ii) Genoa, Italy, and iii) Rennes, France (all controls).\n\nPosaconazole prophylaxis for ICU patients with severe COVID-19 requiring ICU admission due to ARDS has been introduced in Graz in July 2020, and cases from Graz will be matched with controls from Rennes and Genoa (matching for days on mechanical ventilation at baseline, Apache II score, age, dexamethasone dosage, and underlying disease).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient (\\> 18 years)\n* PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection\n* Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection\n\nExclusion Criteria:\n\n* Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission)\n* History of invasive aspergillosis within the prior six months\n* Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection\n* Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection\n* Death or transfer to general ward within 48 hours of ICU admission\n* Antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin B)'}, 'identificationModule': {'nctId': 'NCT05065658', 'acronym': 'POSACOVID', 'briefTitle': 'Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study', 'orgStudyIdInfo': {'id': '32-296 ex 19/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Critically-ill COVID-19 patients receiving posaconazole prophylaxis', 'interventionNames': ['Drug: Posaconazole']}, {'label': 'Critically-ill COVID-19 patients without antifungal prophylaxis'}], 'interventions': [{'name': 'Posaconazole', 'type': 'DRUG', 'description': 'Intravenous posaconazole prophylaxis', 'armGroupLabels': ['Critically-ill COVID-19 patients receiving posaconazole prophylaxis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'country': 'Austria', 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'University of Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'San Martino Polyclinic Hospital IRCCS', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}