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Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia

NCT04851015 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-02-20

No results posted yet for this study

Summary

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. The frequency of adverse events increases in a dose dependent manner and commonly limits the use of TMP-SMX.

Reduced treatment doses of TMP-SMX for PCP reduced ADEs without mortality differences in a recent meta-analysis of observational studies. We therefore propose a Phase III randomized, placebo-controlled trial to directly compare the efficacy and safety of low dose (10 mg/kg/day of TMP) compared to the standard-of-care (15 mg/kg/day) among patients with PCP for the primary outcome of Win Ratio hierarchical composite of death, ECMO, invasive ventilation, grade 4 toxicity, non-invasive ventilation, change of therapy and length of stay.

Conditions

  • Pneumocystis Jirovecii Infection
  • Pneumocystis
  • Pneumocystis Pneumonia
  • Pneumocystis Infections
  • Pneumocystis Carinii Infection
  • Pneumocystosis; Pneumonia (Etiology)
  • Pneumocystis Carinii; Infection, Resulting From HIV Disease
  • Pneumocystosis Associated With AIDS

Interventions

DRUG

trimethoprim-sulfamethoxazole

10mg/kg/day of TMP component

DRUG

trimethoprim-sulfamethoxazole

15mg/kg/day of TMP component

Sponsors & Collaborators

  • Todd C. Lee MD MPH FIDSA

    lead OTHER

Principal Investigators

  • Emily G McDonald, MD MSc · Research Institute of the McGill University Health Centre

  • Todd C Lee, MD MPH FIDSA · Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-28
Primary Completion
2030-09-30
Completion
2030-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851015 on ClinicalTrials.gov