How Long Should we Give Steroids for Patients With Severe PCP (NCT07328984) | Clinical Trial Compass
Not Yet RecruitingPhase 4
How Long Should we Give Steroids for Patients With Severe PCP
Canada416 participantsStarted 2026-01-30
Plain-language summary
The HOW LONG trial is an international, multicenter, Phase IV randomized clinical trial evaluating the optimal duration of adjunctive systemic corticosteroids in immunocompromised adults with severe Pneumocystis jirovecii pneumonia (PCP) who demonstrate early clinical recovery. Participants who no longer require supplemental oxygen by day 10 of corticosteroid therapy are randomized to discontinue corticosteroids at day 10 (or hospital discharge, if earlier) versus continue corticosteroids for a total of 21 days. The trial assesses whether earlier discontinuation reduces steroid-related complications while maintaining clinical outcomes.
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:
* Age ≥18 years
* Proven or probable Pneumocystis jirovecii pneumonia
* Severe PCP requiring supplemental oxygen (e.g., ≥4 L/min or ≥35% FiO₂ to maintain SpO₂ ≥94%)
* Planned or receiving adjunctive systemic corticosteroid therapy for severe PCP
* Clinical recovery by day 10 of steroid therapy: breathing room air for ≥6 hours
* Able to provide informed consent (or per local requirements)
Exclusion Criteria:
* Persistent hypoxemia or ongoing oxygen requirement at day 10
* Clinical deterioration prior to randomization
* Treating clinician determines steroids must be continued or stopped immediately for medical reasons
* Anticipated death within 48 hours
* Inability or unwillingness to complete follow-up through day 180
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 trial is comparing different lengths of steroid treatment for severe PCP — can you explain what steroid duration options are being studied, and how that compares to what I would receive as standard care right now?
2Since this is a Phase 4 trial, does that mean the steroid treatments being tested are already approved and in use, and what does that tell us about what's already known about their safety?
3The trial isn't recruiting yet — given my current situation, should we be moving forward with standard treatment now, or is it worth waiting to see if I could eventually participate in this study?
4The trial uses something called a 'hierarchical composite clinical outcome' to measure results — what does that mean in practical terms, and what health outcomes will they actually be tracking for patients like me?
5For someone with severe PCP, how do the potential benefits of participating in a study that carefully evaluates steroid duration weigh against just following the current standard treatment approach you'd recommend for me?
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
Hierarchical composite clinical outcome
Timeframe: Day 60
Trial details
NCT IDNCT07328984
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre