Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

Completed

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

• Registration Number: NCT05707156
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2023-01-20
• Study First Submitted QC: 2023-01-20
• Study First Posted: 2023-01-31
• Study Start: 2023-07-05
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12032

Inclusion Criteria

• Patients on systemic corticosteroids for more than 2 weeks

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Exclusion Criteria

• HIV infection
• Transplant status
• Younger than 18 years of age
• Previous history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PJP	3-6 months after first corticosteroid use	Number of cases of Pneumocystis jirovecii pneumonia
Cryptococcosis	3-6 months after first corticosteroid use	Number of cases of cryptococcosis
Aspergillosis	3-6 months after first corticosteroid use	Number of cases of Aspergillosis
Candidiasis	3-6 months after first corticosteroid use	Number of cases of Candidiasis

Secondary Outcome Measures

Name	Time	Method
Mortality	3-6 months after first corticosteroid use	Number of deaths
Hospitalization	3-6 months after first corticosteroid use	Number of hospitalization episodes

Trial Locations

Locations (1)

TrinetX based global network; 🇺🇸 Denver, Colorado, United States