An observational study in Pneumocystis Jirovecii Infection, Pneumocystis and Cryptococcosis, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University of Colorado, Denver · Observational
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.
108 studies on the registry are indexed under Pneumonia, Pneumocystis; 16 are open to participants now.
This study's enrollment of 12,032 is above the median of 250 across 29 observational studies indexed under Pneumonia, Pneumocystis.
Browse Pneumonia, Pneumocystis studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Non-HIV, non-transplant immunocompromised individuals on systemic corticosteroids
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
PJP
Number of cases of Pneumocystis jirovecii pneumonia
Time frame: 3-6 months after first corticosteroid use
Cryptococcosis
Number of cases of cryptococcosis
Time frame: 3-6 months after first corticosteroid use
Aspergillosis
Number of cases of Aspergillosis
Time frame: 3-6 months after first corticosteroid use
Candidiasis
Number of cases of Candidiasis
Time frame: 3-6 months after first corticosteroid use
Mortality
Number of deaths
Time frame: 3-6 months after first corticosteroid use
Hospitalization
Number of hospitalization episodes
Time frame: 3-6 months after first corticosteroid use
Plan to share: No — Not available, not applicable
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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