Clinical trial 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 (Reduced dose)?
An investigational antibiotic combination being studied as a potential treatment for Pneumocystis jirovecii pneumonia (PCP). It is designed to inhibit bacterial folate synthesis by blocking dihydrofolate reductase and dihydropteroate synthase.
Also referred to as TMP‑SMX.
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
- This study is testing whether a lower dose of trimethoprim‑sulfamethoxazole works as well as the standard dose for treating PCP, while causing fewer side effects.
- Who it's for
- You may be able to join if you have PCP and are being treated with TMP‑SMX.
- What's involved
- You would receive either the lower dose or the usual dose of TMP‑SMX. You will have regular check‑ups and blood tests to monitor your health.
- Time commitment
- The study lasts about 4 weeks, with visits at the start, during treatment, and after treatment to track your progress.
- 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
- Previously enrolled
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.