Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05707156
Status:
COMPLETED
Last Update Posted:
2025-04-02
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016720', 'term': 'Pneumocystis Infections'}, {'id': 'D011020', 'term': 'Pneumonia, Pneumocystis'}, {'id': 'D003453', 'term': 'Cryptococcosis'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D001228', 'term': 'Aspergillosis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12032}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PJP', 'timeFrame': '3-6 months after first corticosteroid use', 'description': 'Number of cases of Pneumocystis jirovecii pneumonia'}, {'measure': 'Cryptococcosis', 'timeFrame': '3-6 months after first corticosteroid use', 'description': 'Number of cases of cryptococcosis'}, {'measure': 'Aspergillosis', 'timeFrame': '3-6 months after first corticosteroid use', 'description': 'Number of cases of Aspergillosis'}, {'measure': 'Candidiasis', 'timeFrame': '3-6 months after first corticosteroid use', 'description': 'Number of cases of Candidiasis'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '3-6 months after first corticosteroid use', 'description': 'Number of deaths'}, {'measure': 'Hospitalization', 'timeFrame': '3-6 months after first corticosteroid use', 'description': 'Number of hospitalization episodes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunocompetent', 'Corticosteroids', 'Pneumocystis carinii', 'Pneumocystis jirovecii', 'mortality', 'HIV-negative patients'], 'conditions': ['Pneumocystis Jirovecii Infection', 'Pneumocystis', 'Cryptococcosis', 'Candidiasis', 'Aspergillosis']}, 'referencesModule': {'references': [{'pmid': '33005696', 'type': 'RESULT', 'citation': 'Mundo W, Morales-Shnaider L, Tewahade S, Wagner E, Archuleta S, Bandali M, Chadalawada S, Johnson SC, Franco-Paredes C, Shapiro L, Henao-Martinez AF. Lower Mortality Associated With Adjuvant Corticosteroid Therapy in Non-HIV-Infected Patients With Pneumocystis jirovecii Pneumonia: A Single-Institution Retrospective US Cohort Study. Open Forum Infect Dis. 2020 Aug 13;7(9):ofaa354. doi: 10.1093/ofid/ofaa354. eCollection 2020 Sep.'}, {'pmid': '34349985', 'type': 'RESULT', 'citation': 'Gharamti AA, Mundo W, Chastain DB, Franco-Paredes C, Henao-Martinez AF, Shapiro L. Pneumocystis jirovecii pneumonia: a proposed novel model of corticosteroid benefit. Ther Adv Infect Dis. 2021 Jul 20;8:20499361211032034. doi: 10.1177/20499361211032034. eCollection 2021 Jan-Dec. No abstract available.'}, {'pmid': '35657109', 'type': 'RESULT', 'citation': 'Chastain DB, Kung VM, Golpayegany S, Jackson BT, Franco-Paredes C, Vargas Barahona L, Thompson GR 3rd, Henao-Martinez AF. Cryptococcosis among hospitalised patients with COVID-19: A multicentre research network study. Mycoses. 2022 Aug;65(8):815-823. doi: 10.1111/myc.13476. Epub 2022 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'Corticosteroids exposure is a common risk factor for invasive fungal infections. Systemic corticosteroid therapy treats several medical conditions, including rejection in solid organ transplant recipients, malignancy, and autoimmune or inflammatory diseases. Corticosteroid exposure is a well-known risk factor for developing PJP. Still, it remains unclear how prior corticosteroid exposure influences the presentation, severity, and mortality of opportunistic fungal infections. The investigators aim to prospectively characterize the corticosteroid use as a dose response to inform risk of invasive fungal infections.', 'detailedDescription': 'The investigators will use TriNetX, a global federated research network that captures anonymous data from electronic medical records (EMRs) of 66 healthcare organizations. The investigators are setting up a prospective observation study of non-HIV, non-transplant (NHNT) patients who are receiving systemic (oral or intravenous) corticosteroids for more than 2 weeks. The investigators are planning on excluding individuals younger than 18 years old with any prior history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis. The investigators will follow 3 cohorts of patients based on their daily cumulative prednisone equivalent dose in mg. Group 1: 0-10 mg a day, group 2: 10-20 mg a day, group 3: \\> 20 mg daily. The investigators will record any incidence of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis based on ICD-10 codes or labs results at 3-6 months intervals. The investigators will record as well additional clinical features for patients including demographics, comorbidities, medications, and limited labs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-HIV, non-transplant immunocompromised individuals on systemic corticosteroids', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on systemic corticosteroids for more than 2 weeks\n\nExclusion Criteria:\n\n* HIV infection\n* Transplant status\n* Younger than 18 years of age\n* Previous history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis'}, 'identificationModule': {'nctId': 'NCT05707156', 'briefTitle': 'Prospective Observational Study on the Incidence of Opportunistic Fungal Infections', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Prospective Observational Study on the Incidence of Opportunistic Fungal Infections Among Non-HIV Non Transplant Patients by Systemic Corticosteroids Dose', 'orgStudyIdInfo': {'id': '18-2577'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low dose', 'description': 'Cumulative dose of corticosteroids 0-10 mg a day (prednisone equivalent) Prednisone: 0-10 mg OR, Dexamethasone: 0-1.5 mg OR, Prednisolone: 0-10 mg OR, Methylprednisolone: 0-8 mg'}, {'label': 'Medium dose', 'description': 'Cumulative dose of corticosteroids 10-20 mg a day (prednisone equivalent):\n\nPrednisone: 11-20 mg OR, Dexamethasone: 1.6-3.0 mg OR, Prednisolone: 11-20 mg OR, Methylprednisolone: 9-16 mg'}, {'label': 'High dose', 'description': 'Cumulative dose of corticosteroid \\>20 mg a day (prednisone equivalent):\n\nPrednisone: \\> 20 mg OR, Dexamethasone: \\> 3.0 mg OR, Prednisolone: \\> 20 mg OR, Methylprednisolone: \\>16 mg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'TrinetX based global network', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'ANDRES F HENAO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not available, not applicable'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Georgia', 'class': 'OTHER'}, {'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}