At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Immunocompromised status from various causes
- ✓Presentation to healthcare facility
- ✓Proven or probable PCP diagnosis by EORTC/MSGERC criteria
- ✕Previous severe adverse reaction to TMP-SMX, sulfa drugs, or formulation components
- ✕Compliant with PCP prophylaxis using TMP-SMX for ≥4 weeks
- ✕More than 96 hours of prior PCP therapy
- ✕Severe hepatic impairment with ALT ≥5 times upper limit of normal
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia
In Brief
A Phase 3 clinical trial evaluating trimethoprim-sulfamethoxazole for Pneumocystis and 7 related conditions. Currently recruiting, targeting 416 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
10mg/kg/day of TMP component
15mg/kg/day of TMP component