MedTrace Logo

TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study

NCT07690410 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2026-07-14

No results posted yet for this study

Summary

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.

Conditions

  • Pneumocystis Jirovecii Pneumonia in Non-HIV Patients

Interventions

DRUG

low-dose TMP-SMX regimen

TMP \<15 mg/kg/day

Sponsors & Collaborators

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Zhejiang Provincial Tongde Hospital

    collaborator OTHER

  • First Affiliated Hospital of Ningbo University

    collaborator NETWORK

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    lead OTHER

Principal Investigators

  • Yangmin Hu · Second Affiliated Hospital, Zhejiang University, School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-12-31
Completion
2029-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07690410 on ClinicalTrials.gov