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Pharmacokinetic/Pharmacodynamic/Toxicodynamic Target Analysis of Intravenous Trimethoprim-Sulfamethoxazole in Patients with Pneumocystis jirovecii Pneumonia: A Prospective Observational Study

Pharmacokinetic/Pharmacodynamic/Toxicodynamic Target Analysis of Intravenous Trimethoprim-Sulfamethoxazole in Patients with Pneumocystis jirovecii Pneumonia: A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111174
Enrollment
Unknown
Registered
2025-10-27
Start date
2025-10-30
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumocystis jirovecii pneumonia

Interventions

Observational group:None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=18 year; 2.Imaging, microbiological, and/or molecular biological results indicating Pneumocystis jirovecii Pneumonia; 3.Previously treated with oral trimethoprim-sulfamethoxazole (SMZ-TMP) tablets but intolerant due to gastrointestinal adverse reactions and intended to switch to SMZ-TMP injection; 4.Willing to undergo therapeutic drug monitoring (TDM) of sulfamethoxazole/trimethoprim; 5.Voluntarily participate in this study, with the patient or their legal representative fully informed and having signed the informed consent form;

Exclusion criteria

Exclusion criteria: 1.Duration of trimethoprim-sulfamethoxazole (SMZ-TMP) injection use < 7 days; 2.Positive pregnancy test or currently breastfeeding; 3.Patients from whom blood samples cannot be obtained;

Design outcomes

Primary

MeasureTime frame
The clinical efficacy of intravenous compound sulfamethoxazole at the end of treatment;

Secondary

MeasureTime frame
All-cause mortality;Safety endpoints (any adverse reactions and laboratory findings, including nephrotoxicity, hepatotoxicity, etc.);PK/PD targets for sulfamethoxazole and trimethoprim;

Countries

China

Contacts

Public ContactZhang Chunhong

The First Affiliated Hospital of Wenzhou Medical University

zch760217@163.com+86 577 55579708

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026