- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707156
Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
May 8, 2023 updated by: University of Colorado, Denver
Prospective Observational Study on the Incidence of Opportunistic Fungal Infections Among Non-HIV Non Transplant Patients by Systemic Corticosteroids Dose
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.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ANDRES F HENAO, MD
- Phone Number: 7208480820
- Email: andres.henaomartinez@cuanschutz.edu
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80045
- Recruiting
- TrinetX based global network
-
Contact:
- ANDRES F HENAO, MD
- Phone Number: 720-848-0820
- Email: andres.henaomartinez@cuanschutz.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Non-HIV, non-transplant immunocompromised individuals on systemic corticosteroids
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PJP
Time Frame: 3-6 months after first corticosteroid use
|
Number of cases of Pneumocystis jirovecii pneumonia
|
3-6 months after first corticosteroid use
|
Cryptococcosis
Time Frame: 3-6 months after first corticosteroid use
|
Number of cases of cryptococcosis
|
3-6 months after first corticosteroid use
|
Aspergillosis
Time Frame: 3-6 months after first corticosteroid use
|
Number of cases of Aspergillosis
|
3-6 months after first corticosteroid use
|
Candidiasis
Time Frame: 3-6 months after first corticosteroid use
|
Number of cases of Candidiasis
|
3-6 months after first corticosteroid use
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 3-6 months after first corticosteroid use
|
Number of deaths
|
3-6 months after first corticosteroid use
|
Hospitalization
Time Frame: 3-6 months after first corticosteroid use
|
Number of hospitalization episodes
|
3-6 months after first corticosteroid use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ANDRES F HENAO, MD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2023
Primary Completion (Anticipated)
August 5, 2023
Study Completion (Anticipated)
February 5, 2024
Study Registration Dates
First Submitted
January 20, 2023
First Submitted That Met QC Criteria
January 20, 2023
First Posted (Actual)
January 31, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 8, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Disease Attributes
- Bacterial Infections and Mycoses
- Lung Diseases, Fungal
- Infections
- Communicable Diseases
- Candidiasis
- Mycoses
- Aspergillosis
- Pneumonia, Pneumocystis
- Cryptococcosis
- Pneumocystis Infections
Other Study ID Numbers
- 18-2577
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not available, not applicable
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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