NCT04851015RecruitingPhase 3
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Source: ClinicalTrials.gov · Last updated 20 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 416 (estimated)
- First submitted
- 12 Apr 2021
- Start date
- Nov 2025
- Primary completion date
- Sept 2030
- Lead sponsor
- Todd C. Lee MD MPH FIDSA
- Diseases
- HIV
- NCT number
- NCT04851015
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 416
- From Nov 2025 to the primary completion date, Sept 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous severe adverse reaction to TMP-SMX, any sulfa drug, or any component of formulation
- More than 96 hours of any therapy for PCP
- Previously enrolled
Other illness
- Hepatic impairment marked by alanine aminotransferase levels ≥5 times the upper limit of normal
- 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);
Other
- Compliant with PCP prophylaxis for ≥4 weeks with TMP-SMX at enrollment
- Known G6PD deficiency
- Known diagnosis of porphyria
- Known pregnancy or breastfeeding (as per Health Canada)
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.