NCT04851015 Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
| NCT ID | NCT04851015 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Todd C. Lee MD MPH FIDSA |
| Condition | Pneumocystis |
| Study Type | INTERVENTIONAL |
| Enrollment | 416 participants |
| Start Date | 2025-11-28 |
| Primary Completion | 2030-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 416 participants in total. It began in 2025-11-28 with a primary completion date of 2030-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 18 years or older * Immunocompromised (including but not limited to HIV, solid organ transplant, solid tumors, hematological stem cell transplant and malignancies, systemic diseases, chemotherapy, long term corticosteroid use, and immunosuppressive therapies, as well as primary immunodeficiencies * Presentation to a day hospital, emergency department, or admitted to hospital * Proven or probable diagnosis of PCP using an adapted version of the 2021 EORTC/MSGERC criteria. Exclusion Criteria: * Previous severe adverse reaction to TMP-SMX, any sulfa drug, or any component of formulation * Compliant with PCP prophylaxis for ≥4 weeks with TMP-SMX at enrollment * More than 96 hours of any therapy for PCP * Hepatic impairment marked by alanine aminotransferase levels ≥5 times the upper limit of normal * Known G6PD deficiency * Known diagnosis of porphyria * Known pregnancy or breastfeeding (as per Health Canada) * Unable to provide informed consent and no available healthcare proxy (with ethics approval for deferred consent in cases of critical illness); refusal of consent; no reliable means of outpatient contact (telephone/email/text); * Previously enrolled
Contact & Investigator
Emily G McDonald, MD MSc
PRINCIPAL INVESTIGATOR
Research Institute of the McGill University Health Centre
Frequently Asked Questions
Who can join the NCT04851015 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Pneumocystis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04851015 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 416 participants.
Is NCT04851015 currently recruiting?
Yes, NCT04851015 is actively recruiting participants. Contact the research team at babykumari.chitramuthu@muhc.mcgill.ca for enrollment information.
Where is the NCT04851015 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04851015 clinical trial?
NCT04851015 is sponsored by Todd C. Lee MD MPH FIDSA. The principal investigator is Emily G McDonald, MD MSc at Research Institute of the McGill University Health Centre. The trial plans to enroll 416 participants.