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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

Pivotal Trial

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion with Treatment failure

Secondary study objectives

EQ-5D-5L

Proportion requiring new non-invasive ventilation

Proportion who die

+11 more

Other study objectives

Proportion with all cause mortality

Proportion with at least 1 recurrence of Pneumocystis

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met