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| Name | Class |
|---|---|
| University of Georgia | OTHER |
| University of California, Davis | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | 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 | 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 | 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Non-HIV, non-transplant immunocompromised individuals on systemic corticosteroids
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| Name | Affiliation | Role |
|---|---|---|
| ANDRES F HENAO, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TrinetX based global network | Denver | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33005696 | Result | 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. | |
| 34349985 |
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| ID | Term |
|---|---|
| D016720 | Pneumocystis Infections |
| D011020 | Pneumonia, Pneumocystis |
| D003453 | Cryptococcosis |
| D002177 | Candidiasis |
| D001228 | Aspergillosis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008172 | Lung Diseases, Fungal |
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| Result |
| 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. |
| 35657109 | Result | 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. |
| D012141 |
| Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |