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OpenTrials
Completed

NCT Number: NCT05707156

Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

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.

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Key information

Conditions

Pneumocystis Jirovecii Infection Aspergillosis Bacterial Infections and Mycoses Candidiasis Cryptococcosis Infections Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

TrinetX based global network

Denver, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PJP

    Time frame: 3-6 months after first corticosteroid use

    Number of cases of Pneumocystis jirovecii pneumonia

  2. Cryptococcosis

    Time frame: 3-6 months after first corticosteroid use

    Number of cases of cryptococcosis

  3. Aspergillosis

    Time frame: 3-6 months after first corticosteroid use

    Number of cases of Aspergillosis

  4. Candidiasis

    Time frame: 3-6 months after first corticosteroid use

    Number of cases of Candidiasis

Secondary outcomes

  1. Mortality

    Time frame: 3-6 months after first corticosteroid use

    Number of deaths

  2. Hospitalization

    Time frame: 3-6 months after first corticosteroid use

    Number of hospitalization episodes

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • University of California, Davis
  • University of Georgia

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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