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Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions: Pneumocystis Pneumonia, Pneumocystis, Pneumocystis Jirovecii Infection, Pneumocystis Jiroveci Pneumonia, Pneumocystis Carinii; Infection, Resulting From HIV Disease
Interventions: Systemic corticosteroids
Countries: Canada
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Montreal, Quebec, Canada