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Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05707156
Enrollment
12032
Registered
2023-01-31
Start date
2023-07-05
Completion date
2024-01-05
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspergillosis, Candidiasis, Cryptococcosis, Pneumocystis, Pneumocystis Jirovecii Infection

Keywords

Immunocompetent, Corticosteroids, Pneumocystis carinii, Pneumocystis jirovecii, mortality, HIV-negative patients

Brief summary

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

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.

Interventions

None listed

Sponsors

University of Georgia
CollaboratorOTHER
University of California, Davis
CollaboratorOTHER
University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PJP3-6 months after first corticosteroid useNumber of cases of Pneumocystis jirovecii pneumonia
Cryptococcosis3-6 months after first corticosteroid useNumber of cases of cryptococcosis
Aspergillosis3-6 months after first corticosteroid useNumber of cases of Aspergillosis
Candidiasis3-6 months after first corticosteroid useNumber of cases of Candidiasis

Secondary

MeasureTime frameDescription
Mortality3-6 months after first corticosteroid useNumber of deaths
Hospitalization3-6 months after first corticosteroid useNumber of hospitalization episodes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026