Actively Recruiting
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Led by Todd C. Lee MD MPH FIDSA · Updated on 2026-02-20
416
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pneumocystis jirovecii pneumonia (PCP) 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 PCP 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 PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay.
CONDITIONS
Official Title
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Immunocompromised due to conditions such as HIV, solid organ transplant, solid tumors, hematological stem cell transplant, malignancies, systemic diseases, chemotherapy, long term corticosteroid use, immunosuppressive therapies, or primary immunodeficiencies
- Presentation to a day hospital, emergency department, or hospital admission
- Proven or probable diagnosis of Pneumocystis jirovecii pneumonia (PCP) using adapted 2021 EORTC/MSGERC criteria
You will not qualify if you...
- Previous severe adverse reaction to trimethoprim-sulfamethoxazole, any sulfa drug, or any component of its formulation
- Receiving PCP prophylaxis with TMP-SMX for 4 weeks or more at enrollment
- More than 96 hours of any therapy for PCP prior to enrollment
- Liver impairment with alanine aminotransferase levels 5 times above the upper normal limit
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Known diagnosis of porphyria
- Pregnant or breastfeeding
- Unable to provide informed consent with no available healthcare proxy; refusal of consent; or no reliable outpatient contact method
- Previously enrolled in this study
AI-Screening
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Trial Site Locations
Total: 1 location
1
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
Research Team
B
Babykumari Chitramuthu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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