Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)
416 participantsStarted 2026-03
Plain-language summary
The usual first treatment for Pneumocystis jirovecii pneumonia (PCP) is an antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX). However, some patients cannot take this medication because of allergies, side effects, or lack of response.
This study asks the question:
When TMP-SMX cannot be used, which alternative treatment for PCP provides the best balance of effectiveness and safety?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Previous severe adverse reaction or hypersensitivity to clindamycin, primaquine, or atovaquone (mild-moderate PCP) or to clindamycin, primaquine, or pentamidine (severe PCP);
. More than 7 calendar days of any therapy for PCP (no more than 4 can involve a study drug).
. Known pregnancy or breastfeeding (pregnancy test will be offered)
. For clindamycin-primaquine:
. Known G6PD deficiency OR family history of G6PD deficiency without excluding by testing\*
. Known diagnosis of porphyria
. Concomitant use of methotrexate or cyclophosphamide which cannot be held \*G6PD deficiency is an X-linked recessive genetic disease. Female patients without a family history are very unlikely to have this disease and so therapy can start while waiting for the test in the absence of a family history. Male patients should wait for test results prior to receiving primaquine even if they do not have a family history. For those without G6PD testing at diagnosis, it is a reasonable standard of care to order testing.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying second-line treatments for Pneumocystis jirovecii pneumonia, which suggests it's for people who haven't responded to or can't tolerate the standard first-line therapy — does my situation fit that profile, and would it be worth discussing this trial as an option?
2Since this is a Phase 4 trial, the treatments being studied have already been approved and used before, but they're being compared more rigorously here — can you explain what that means for what's already known about their safety and effectiveness compared to what I might receive outside a trial?
3The trial isn't recruiting yet, so there could be a wait before I could even enroll — given how serious PCP can be, is waiting for this trial realistic, or should we be moving forward with an available treatment now?
4The trial is measuring something called a 'hierarchical composite outcome,' which likely combines multiple health results into one measure — can you walk me through what specific outcomes they're tracking and how those relate to what matters most to me in my recovery?
5My PCP may be connected to HIV or another condition affecting my immune system — how would my underlying diagnosis affect whether this trial might be appropriate for me to discuss with the care team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hierarchical composite outcome
Timeframe: Day 30
Trial details
NCT IDNCT07357103
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre