NCT07328984Not yet recruitingPhase 4
How Long Should we Give Steroids for Patients With Severe PCP
How Long Should we Give Steroids for Patients With Severe PCP (HOW LONG)
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 416 (estimated)
- First submitted
- 15 Dec 2025
- Start date
- 30 Jan 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Diseases
- HIV
- NCT number
- NCT07328984
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 416
- From 30 Jan 2026 to the primary completion date, 31 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinical deterioration prior to randomization
- Treating clinician determines steroids must be continued or stopped immediately for medical reasons
Other
- Persistent hypoxemia or ongoing oxygen requirement at day 10
- Anticipated death within 48 hours
- Inability or unwillingness to complete follow-up through day 180
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.