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Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions: Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
Interventions: low-dose TMP-SMX regimen
Pneumocystis jirovecii pneumonia (PCP) is a life-threatening opportunistic infection in immunocompromised patients. Non-HIV-related PCP has a rising incidence, faster progression, and higher mortality than HIV-associated cases. Trimethoprim-sulfamethoxazole (TMP/SMX) is first-line, but standard dosing (TMP 15-20 mg/kg/day) is associated with adverse reaction rates of 56%-72%, and prospective evidence is scarce. This prospective, multicentre, observational study aims to compare the efficacy and safety of low-dose (TMP \<15 mg/kg/day) versus conventional-dose TMP/SMX for non-HIV-related PCP, and to explore the value of therapeutic drug monitoring in individualising therapy, without interfering with routine clinical decisions. The investigators plan to enrol 480 patients aged ≥18 years with confirmed non-HIV-related PCP receiving TMP/SMX as initial treatment, excluding those with allergy, prophylaxis, treatment \<72 hours, or supratherapeutic dosing. The primary outcome is treatment failure at day 21 (all-cause death or new invasive ventilation). Secondary outcomes include day-8 oxygenation change, 30- and 90-day mortality, regimen completion, adverse events (CTCAE v6.0), and hospital/ICU stay. Propensity score matching will be the main analysis, with inverse probability weighting for sensitivity.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Inclusion Criteria: * Age ≥18 years, * Meet the diagnostic criteria for Non-HIV-associated PCP, * Receiving TMP/SMX as the initial treatment for PCP, * Provide written informed consent to participate in the study. Exclusion Criteria: * Pregnant or breastfeeding women, * History of severe allergy or documented intolerance to TMP/SMX, * TMP/SMX used for PCP prophylaxis rather than treatment, * TMP/SMX treatment duration \<72 hours at the time of screening, * TMP/SMX administered at a supratherapeutic dose (TMP component \>20 mg/kg/day).