Prospective Observational Study on the Incidence of Opportunistic Fungal Infections

Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707156
• Other study ID #: 18-2577
• Status: Recruiting
• Start date: February 5, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: ANDRES F HENAO, MD
• Phone: 7208480820
• Email: andres.henaomartinez[@]cuanschutz.edu
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 2000
• Est. completion date: February 5, 2024
• Est. primary completion date: August 5, 2023
• 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

Related Conditions & MeSH terms

• Aspergillosis
• Candidiasis
• Communicable Diseases
• Cryptococcosis
• Infections
• Mycoses
• Pneumocystis
• Pneumocystis Infections
• Pneumocystis Jirovecii Infection
• Pneumonia, Pneumocystis

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