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New treatment option for Pneumocystis
Official title Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
ClinicalTrials.gov ID: NCT04851015
What this study is testing
What is trimethoprim-sulfamethoxazole?
trimethoprim-sulfamethoxazole is an investigational medicine, being studied as a potential treatment for pneumocystis.
Also referred to as Reduced dose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 18 years or older
- Immunocompromised (including but not limited to HIV, solid organ transplant, solid tumors, hematological stem cell transplant and malignancies...
- 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.
You likely can't join if
- 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
See the full eligibility 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...
- 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.
- 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...
- Previously enrolled
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.