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

NCT07690410 | Not Yet Recruiting

• 1 other identifier: 2026-0430
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Trimethoprim-Sulfamethoxazole; Prospective Studies; Multicenter Study; Pneumocystis jirovecii; Pneumonia

Outcome Measures

Primary Outcomes (1)

• Treatment Failure at Day 21

  Composite of all-cause death or new invasive mechanical ventilation (including escalation from non-invasive to invasive) within 21 days of treatment initiation.

  Up to 21 days

Study Arms (1)

conventional-dose TMP-SMX regimen

TMP 15-20 mg/kg/day

Drug: low-dose TMP-SMX regimen

Interventions

low-dose TMP-SMX regimen DRUG

TMP \<15 mg/kg/day

conventional-dose TMP-SMX regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study plans to enrol hospitalised patients aged ≥18 years with confirmed non-HIV-related Pneumocystis jirovecii pneumonia (PCP) who are receiving trimethoprim-sulfamethoxazole (TMP/SMX) as initial therapy. Participants will be recruited from the departments of respiratory medicine, intensive care units, and related clinical wards across 4 participating hospitals in China.

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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang Provincial Tongde Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• First Affiliated Hospital of Ningbo University: collaborator

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yangmin Hu

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yangmin Hu

CONTACT

+86 057187783891; zrhym@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-06