Prospective Observational Study on the Incidence of Opportunistic Fungal Infections (NCT05707156) | Clinical Trial Compass
CompletedNot Applicable
Prospective Observational Study on the Incidence of Opportunistic Fungal Infections
United States12,032 participantsStarted 2023-07-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study tracked how often serious fungal infections like Pneumocystis jirovecii pneumonia, Cryptococcosis, Aspergillosis, and Candidiasis actually occurred in patients — can you tell me what the results showed and whether my specific situation puts me at higher risk for any of these infections?
2Since this was an observational study rather than a treatment trial, it was watching and recording infections rather than testing a new therapy — does that mean the findings might help guide decisions about whether I should be on preventive antifungal medication?
3The study has already completed recruitment, so results may be available — have you seen any published findings from this research that could influence how you'd monitor me for opportunistic fungal infections?
4Given that this study focused on opportunistic fungal infections, which tend to affect people with weakened immune systems, can we talk about whether my current health condition or any treatments I'm on put me at risk for any of these specific infections?
5Since this was an observational study collecting real-world incidence data on these fungal infections, would its findings change anything about the routine screenings or precautions you'd recommend for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PJP
Timeframe: 3-6 months after first corticosteroid use
2
Cryptococcosis
Timeframe: 3-6 months after first corticosteroid use
3
Aspergillosis
Timeframe: 3-6 months after first corticosteroid use
4
Candidiasis
Timeframe: 3-6 months after first corticosteroid use