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

Study acronym: LOW-DOSE
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre to Todd C. Lee MD MPH FIDSAv6 Show 10 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 2028 to Sep 30, 2030
    • Start date changed from estimate of Jan 2025 to Nov 28, 2025
    • Primary endpoint revised
    • Enrollment target: 300 to 416
    • Study completion date: Jun 2028 to Dec 31, 2030
    • Secondary endpoints: 16 to 7
    • Study description expanded, about 19 words
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  2. Start date: Sep 2024 to Jan 2025v5
  3. Primary completion date: Dec 2025 to Mar 2028
    • Start date: Jun 2022 to Sep 2024
    • Study completion date: Mar 2026 to Jun 2028
    v4
  4. Primary completion date: Dec 2024 to Dec 2025
    • Start date: Jun 2021 to Jun 2022
    • Study completion date: Mar 2025 to Mar 2026
    v3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04851015
Lead Sponsor Todd C. Lee MD MPH FIDSA
Conditions
(from sponsor)		 Pneumocystis, Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection, Pneumocystis Infections, Pneumocystis Carinii Infection, Pneumocystosis; Pneumonia (Etiology), Pneumocystis Carinii; Infection, Resulting From HIV Disease, Pneumocystosis Associated With AIDS
Related terms Infections, Pneumocystis Infections, Pneumonia, Pneumonia, Pneumocystis
Enrollment 416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov