How Long Should we Give Steroids for Patients With Severe PCP

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Systemic corticosteroids

Treatment groups

416 Participants
are divided into 2 treatment groups