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

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Apr 14, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a lower dose of a medication called trimethoprim-sulfamethoxazole (TMP-SMX) to treat a serious lung infection known as Pneumocystis jirovecii pneumonia (PJP). This infection mainly affects people with weakened immune systems, such as those with HIV, cancer, or who have had organ transplants. The standard treatment dose can cause significant side effects, which is why researchers want to see if a lower dose (10 mg/kg/day) is just as effective but with fewer harmful effects compared to the usual higher dose (15 mg/kg/day).

To qualify for this trial, participants must be immunocompromised and have a confirmed or likely diagnosis of PJP. They should also be seeking treatment in a hospital or emergency setting. However, people who have previously had severe reactions to the study medication or who have certain medical conditions, like liver problems or pregnancy, cannot participate. If someone joins the trial, they will receive either the lower or standard dose of the medication and be monitored for their health outcomes, including any side effects and overall effectiveness of the treatment. This study aims to find a safer way to treat PJP while still helping patients recover effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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