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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05707156
Other study ID # 18-2577
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2023
Est. completion date January 5, 2024

Study information

Verified date May 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12032
Est. completion date January 5, 2024
Est. primary completion date January 5, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
United States TrinetX based global network Denver Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Denver University of California, Davis, University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (3)

Chastain DB, Kung VM, Golpayegany S, Jackson BT, Franco-Paredes C, Vargas Barahona L, Thompson GR 3rd, Henao-Martinez AF. Cryptococcosis among hospitalised patients with COVID-19: A multicentre research network study. Mycoses. 2022 Aug;65(8):815-823. doi: — View Citation

Gharamti AA, Mundo W, Chastain DB, Franco-Paredes C, Henao-Martinez AF, Shapiro L. Pneumocystis jirovecii pneumonia: a proposed novel model of corticosteroid benefit. Ther Adv Infect Dis. 2021 Jul 20;8:20499361211032034. doi: 10.1177/20499361211032034. eC — View Citation

Mundo W, Morales-Shnaider L, Tewahade S, Wagner E, Archuleta S, Bandali M, Chadalawada S, Johnson SC, Franco-Paredes C, Shapiro L, Henao-Martinez AF. Lower Mortality Associated With Adjuvant Corticosteroid Therapy in Non-HIV-Infected Patients With Pneumoc — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PJP Number of cases of Pneumocystis jirovecii pneumonia 3-6 months after first corticosteroid use
Primary Cryptococcosis Number of cases of cryptococcosis 3-6 months after first corticosteroid use
Primary Aspergillosis Number of cases of Aspergillosis 3-6 months after first corticosteroid use
Primary Candidiasis Number of cases of Candidiasis 3-6 months after first corticosteroid use
Secondary Mortality Number of deaths 3-6 months after first corticosteroid use
Secondary Hospitalization Number of hospitalization episodes 3-6 months after first corticosteroid use
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