TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: low-dose TMP-SMX regimen.
- Who it may be relevant to
- Registry conditions: Pneumocystis Jirovecii Pneumonia in Non-HIV Patients. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of TMP-SMX for Non-HIV-Related PCP: A Prospective Multicenter Observational Study
Overview
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.
Interventions
- Drug low-dose TMP-SMX regimen
TMP \<15 mg/kg/day
Primary outcome measures
- Treatment Failure at Day 21 [Time frame: Up to 21 days]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07690410 · 2026-0430