Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Candidiasis; Pneumocystis; Aspergillosis; Cryptococcosis; Pneumocystis Jirovecii Infection

Study type: Observational

Funder types: Other

Identifiers

NCT05707156

18-2577

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,032 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

12,032 participants in 3 patient groups

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

Medium dose

Description:

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

Description:

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