Low-dose trimethoprim-sulfamethoxazole treatment for Pneumocystis (PCP) pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III randomized, double-blind, controlled trial compares low-dose TMP‑SMX (10 mg/kg/day of trimethoprim) to standard-dose TMP‑SMX (15 mg/kg/day) for treatment of proven or probable PCP in immunocompromised adults. Participants are randomized early in therapy (within 96 hours of treatment initiation) and are enrolled at the McGill University Health Centre. The primary outcome is a Win Ratio hierarchical composite that includes death, extracorporeal membrane oxygenation (ECMO), and invasive ventilation, with secondary endpoints addressing adverse drug events and treatment tolerability. The trial is designed to test noninferiority in clinical outcomes while measuring differences in toxicity rates.

Why it matters

Who can join: the full rules

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

Where it's running

• McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Emily G McDonald, MD MSc — Research Institute of the McGill University Health Centre
• Study coordinator: Babykumari Chitramuthu, PhD
• Email: babykumari.chitramuthu@muhc.mcgill.ca
• Phone: 514-934-1934

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.