TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
Starting soon
Conditions studied: Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
In brief
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.
Key facts
- Study ID
- NCT07690410
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 480
- Starts
- 2026-08-01
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Full record on ClinicalTrials.gov
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