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Anti-infective

Low-Dose Trimethoprim-Sulfamethoxazole for Pneumocystis Pneumonia (LOW-TMP Trial)

Phase 3
Waitlist Available
Led By Emily G McDonald, MD MSc
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presentation to a day hospital, emergency department, or admitted to hospital
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

LOW-TMP Trial Summary

This trial will compare the efficacy and safety of a reduced treatment dose of TMP-SMX for PJP against the standard-of-care.

Who is the study for?
This trial is for immunocompromised individuals, including those with HIV, organ transplants, cancers, or on long-term steroids. They must have a proven or probable PJP diagnosis and can be in the hospital or just visiting. People who've had bad reactions to TMP-SMX/sulfa drugs, certain liver issues, started other PJP treatments over 72 hours ago, pregnant/breastfeeding women, or unable to consent are excluded.Check my eligibility
What is being tested?
The study tests if a lower dose of Trimethoprim-Sulfamethoxazole (10 mg/kg/day) is as effective and safer than the standard dose (15 mg/kg/day) for treating Pneumocystis jirovecii pneumonia. It's a Phase III trial where patients are randomly assigned to receive either the low dose or standard treatment.See study design
What are the potential side effects?
Possible side effects include hypersensitivity reactions like rashes and itching; drug-induced liver injury; blood cell count changes leading to anemia; and kidney problems which could manifest as reduced urine output or swelling.

LOW-TMP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recently visited a hospital for my condition.
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I have a weakened immune system due to a condition or treatment.

LOW-TMP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion with Treatment failure
Secondary outcome measures
EQ-5D-5L
Proportion requiring new non-invasive ventilation
Proportion who die
+11 more
Other outcome measures
Proportion with all cause mortality
Proportion with at least 1 recurrence of Pneumocystis

LOW-TMP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced dose TMP-SMXExperimental Treatment1 Intervention
Trimethoprim-Sulfamethoxazole at a total dose of 10mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as a dose of 10mg/kg/day open label with additional placebo tablets or intravenous placebo solution given to simulate 15mg/kg/day. All doses will be adjusted for obesity and renal function.
Group II: Standard dose TMP-SMXActive Control1 Intervention
Trimethoprim-Sulfamethoxazole at a total dose of 15mg/kg/day. Oral or intravenous drug will be administered at discretion of treating team. This will be given as 10mg/kg/day open label plus an extra masked 5mg/kg/day of tablets or intravenous solution. All doses will be adjusted for obesity and renal function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
trimethoprim-sulfamethoxazole
2020
Completed Phase 4
~2920

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
441 Previous Clinical Trials
158,770 Total Patients Enrolled
Emily G McDonald, MD MScPrincipal InvestigatorResearch Institute of the McGill University Health Centre
3 Previous Clinical Trials
662 Total Patients Enrolled
Zahra N Sohani, MD PhDPrincipal InvestigatorResearch Institute of the McGill University Health Centre

Media Library

Trimethoprim-Sulfamethoxazole (Anti-infective) Clinical Trial Eligibility Overview. Trial Name: NCT04851015 — Phase 3
Pneumocystis Pneumonia Research Study Groups: Reduced dose TMP-SMX, Standard dose TMP-SMX
Pneumocystis Pneumonia Clinical Trial 2023: Trimethoprim-Sulfamethoxazole Highlights & Side Effects. Trial Name: NCT04851015 — Phase 3
Trimethoprim-Sulfamethoxazole (Anti-infective) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04851015 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being administered this treatment?

"This trial is no longer recruiting patients. The study was first posted on 6/1/2022 and was most recently updated on 4/5/2022. If you are looking for other studies, there are 968 trials actively admitting patients with pneumocystis and 15 studies for trimethoprim-sulfamethoxazole currently seeking participants."

Answered by AI

Are we still looking for participants for this experiment?

"Unfortunately, this particular study is not currently seeking new participants. However, it was last updated on April 5th, 2022 and originally posted June 1st of the same year. There are 983 other trials that are actively recruiting patients right now."

Answered by AI

Does this research include patients that are over 55 years old?

"According to the requirements listed, people aged 18 to 100 are eligible for this trial. Out of the 788 trials available for patients over 65 and 242 studies for those under 18, this is the most promising opportunity."

Answered by AI

How can I get involved in this experiment?

"This clinical trial is looking for 300 patients who currently have pneumocystis and meet the following criteria: they must be between the ages of 18 and 100, 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 or emergency department or admitted to hospital. Proven or probable diagnosis of PJP using an adapted version of the 2021 EORTC/MS"

Answered by AI

What infections does trimethoprim-sulfamethoxazole commonly target?

"Trimethoprim-sulfamethoxazole is an effective antibiotic treatment for shigella sonnei-caused enteritis, otitis media, and shigellosis."

Answered by AI

Is this the first investigation of trimethoprim-sulfamethoxazole?

"There are currently 15 ongoing trimethoprim-sulfamethoxazole trials, 3 of which have progressed to Phase 3. While the majority of these research projects are based in Montreal, Quebec - there are a total of 38 locations running clinical trials for this medication."

Answered by AI

Has the FDA cleared trimethoprim-sulfamethoxazole for use?

"There is some evidence from prior trials to support the efficacy of trimethoprim-sulfamethoxazole, as well as multiple rounds of data demonstrating its safety. Consequently, our team has rated it a 3 on our scale."

Answered by AI
~136 spots leftby Dec 2025