Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05707156

Collaborator

University of California, Davis (Other), University of Georgia (Other)

2,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumocystis Jirovecii Infection Pneumocystis Cryptococcosis Candidiasis Aspergillosis

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Feb 5, 2023

Anticipated Primary Completion Date :

Aug 5, 2023

Anticipated Study Completion Date :

Feb 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Mortality [3-6 months after first corticosteroid use]
Number of deaths
Hospitalization [3-6 months after first corticosteroid use]
Number of hospitalization episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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