Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective Observational Study on the Incidence of Opportunistic Fungal Infections Among Non-HIV Non Transplant Patients by Systemic Corticosteroids Dose

Conditions
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Pneumocystis, Pneumocystis Jirovecii Infection, Cryptococcosis, Candidiasis, Aspergillosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on systemic corticosteroids for more than 2 weeks Exclusion Criteria: HIV infection Transplant status Younger than 18 years of age Previous history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low dose<br>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 | |
| Medium dose<br>Cumulative dose of corticosteroids 10-20 mg a day (prednisone equivalent): Prednisone: 11-20 mg OR, Dexamethasone: 1.6-3.0 mg OR, Prednisolone: 11-20 mg OR, Methylprednisolone: 9-16 mg | |
| High dose<br>Cumulative dose of corticosteroid >20 mg a day (prednisone equivalent): Prednisone: > 20 mg OR, Dexamethasone: > 3.0 mg OR, Prednisolone: > 20 mg OR, Methylprednisolone: >16 mg | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PJP | Number of cases of Pneumocystis jirovecii pneumonia | 3-6 months after first corticosteroid use | 
| Cryptococcosis | Number of cases of cryptococcosis | 3-6 months after first corticosteroid use | 
| Aspergillosis | Number of cases of Aspergillosis | 3-6 months after first corticosteroid use | 
| Candidiasis | Number of cases of Candidiasis | 3-6 months after first corticosteroid use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Number of deaths | 3-6 months after first corticosteroid use | 
| Hospitalization | Number of hospitalization episodes | 3-6 months after first corticosteroid use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunocompetent, Corticosteroids, Pneumocystis carinii, Pneumocystis jirovecii, mortality, HIV-negative patients