Clinical trial NCT05707156: Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
Official title: Prospective Observational Study on the Incidence of Opportunistic Fungal Infections Among Non-HIV Non Transplant Patients by Systemic Corticosteroids Dose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumocystis Jirovecii Infection
Pneumocystis
Cryptococcosis
Candidiasis
Aspergillosis
Keywords: Immunocompetent
Corticosteroids
Pneumocystis carinii
Pneumocystis jirovecii
mortality
HIV-negative patients
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Georgia
name: University of California, Davis
First posted: 2023-01-31
Enrollment: 12032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-HIV, non-transplant immunocompromised individuals on systemic corticosteroids

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.

Eligibility criteria: 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

Primary outcomes:
measure: PJP
timeFrame: 3-6 months after first corticosteroid use
measure: Cryptococcosis
timeFrame: 3-6 months after first corticosteroid use
measure: Aspergillosis
timeFrame: 3-6 months after first corticosteroid use
measure: Candidiasis
timeFrame: 3-6 months after first corticosteroid use
Secondary outcomes:
measure: Mortality
timeFrame: 3-6 months after first corticosteroid use
measure: Hospitalization
timeFrame: 3-6 months after first corticosteroid use
Other outcomes:
Locations:
city: Denver
country: United States
facility: TrinetX based global network
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: ANDRES F HENAO, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Pneumocystis jirovecii Pneumonia: A Single-Institution Retrospective US Cohort Study. Open Forum Infect Dis. 2020 Aug 13;7(9):ofaa354. doi: 10.1093/ofid/ofaa354. eCollection 2020 Sep.
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. eCollection 2021 Jan-Dec. No abstract available.
citation: 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: 10.1111/myc.13476. Epub 2022 Jun 19.