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

July 1, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Efficacy and Safety of TMP-SMX for Non-HIV-Related PCP: A Prospective Multicenter Observational Study

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.

We 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

1.Age ≥18 years, 2.Meet the diagnostic criteria for non-HIV-related PCP, 3.Receiving TMP/SMX as the initial treatment for PCP, 4.Provide written informed consent to participate in the study.

Exclusion Criteria:

1.Pregnant or breastfeeding women, 2.History of severe allergy or documented intolerance to TMP/SMX, 3.TMP/SMX used for PCP prophylaxis rather than treatment, 4.TMP/SMX treatment duration <72 hours at the time of screening, 5.TMP/SMX administered at a supratherapeutic dose (TMP component >20 mg/kg/day).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conventional-dose TMP-SMX regimen
TMP 15-20 mg/kg/day
Drug: low-dose TMP-SMX regimen
TMP <15 mg/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Failure at Day 21
Time Frame: Up to 21 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

First Affiliated Hospital of Wenzhou Medical University
Zhejiang Provincial Tongde Hospital
First Affiliated Hospital of Ningbo University

Investigators

  • Principal Investigator: Yangmin Hu, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0430

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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