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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)
Must not have
Known diagnosis of porphyria
Known G6PD deficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with porphyria.
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I have been diagnosed with G6PD deficiency.
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My liver enzyme levels are very high.
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I have been taking medication to prevent a specific lung infection for at least 4 weeks.

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

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
452 Previous Clinical Trials
161,592 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
~114 spots leftby Dec 2025
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