Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Status:
Not yet recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection of
immunocompromised hosts which causes in significant morbidity and mortality. The current
standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day of
TMP, is associated with serious adverse events, including hypersensitivity reactions,
drug-induced liver injury, cytopenia, and renal failure occurring among 20-60% of patients.
The frequency of adverse events increases in a dose dependent manner and commonly limits the
use of TMP-SMX.
Reduced treatment doses of TMP-SMX for PJP reduced ADEs without mortality differences in a
recent meta-analysis of observational studies. We therefore propose a Phase III randomized,
placebo-controlled trial to directly compare the efficacy and safety of low dose (10
mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PJP for
the primary outcome of death, new mechanical ventilation, and change of treatment.
Phase:
Phase 3
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Treatments:
Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination