Status:
NOT_YET_RECRUITING
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Pneumocystis
Pneumocystis Pneumonia
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection of immunocompromised hosts which causes in significant morbidity and mortality. The current standard of care, trimethoprim-s...
Detailed Description
Pneumocystis jirovecii pneumonia (PJP) is an opportunistic fungal infection primarily affecting immunocompromised patients. Adults with HIV (particularly CD4 ≤200 cells/µL), solid organ and allogeneic...
Eligibility Criteria
Inclusion
- 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 PJP using an adapted version of the 2021 EORTC/MSGERC criteria.
Exclusion
- Previous severe adverse reaction to TMP-SMX, any sulfa drug, or any component of formulation
- Compliant with PJP prophylaxis for ≥4 weeks with TMP-SMX at enrollment
- More than 72 hours of any therapy for PJP
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04851015
Start Date
January 1 2025
End Date
June 1 2028
Last Update
November 19 2024
Active Locations (1)
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1
McGill University Health Centre (Royal Victoria Hospital and Montreal General Hospital)
Montreal, Quebec, Canada, H4A3J1