🌐 EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia

RecruitingPhase 3Ages 18 Years - 100 YearsAllTodd C. Lee MD MPH FIDSA
NCT04851015 on ClinicalTrials.gov ↗
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
📋 Eligibility rules (as published)
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
💊

What it tests

  • trimethoprim-sulfamethoxazole
  • trimethoprim-sulfamethoxazole
📍

Where

1 site
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy