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.
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
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
Parallel
Systemic corticosteroids
DrugAdjunctive systemiccorticosteroid therapy administered as part of standard treatment for pneumocystis Pneumonia, with duration varying by study arm.
Hierarchical composite clinical outcome
The primary outcome at day 60 will be the hierarchical composite of: 1. death, 2. relapse of PCP-related hypoxemia (e.g., not due to another obviously identified cause like pulmonary embolism, aspiration event, etc.) requiring more than 12 hours of use of ≥2L of oxygen in accordance with guidelines 3. The development of secondary infections requiring systemic antibiotic therapy 4. The development of severe diabetic complications (ketoacidosis, hyperosmolar coma, new initiation of insulin which is continued at discharge) 5. The development of severe GI bleeding (e.g., necessitating unplanned transfusion and/or endoscopy) and; 6. inpatient length of stay (censored at day 60; deaths assigned 60 days).
Death
Mortality at day 60
relapse of PCP-related hypoxemia
(Relapse of PCP-related hypoxemia that is not due to another obviously identified cause like pulmonary embolism, aspiration event, etc.) requiring more than 12 hours of use of ≥2L of oxygen in accordance with guidelines
Secondary infections requiring systemic antibiotic therapy
The development of secondary infections requiring systemic antibiotic therapy
The development of severe diabetic complications
Severe complications of diabetes include: ketoacidosis, hyperosmolar coma, new initiation of insulin which is continued at discharge
Quality of life (EQ-5D-5L)
Higher score indicates better quality of life
Quality of life (EQ-5D-5L)
Higher score indicates better quality of life
All-cause mortality
all cause mortality
PCP recurrence
recurrence of PCP infection following the initial infection
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