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

ConditionPneumocystis Jirovecii Pneumonia in Non-HIV Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • low-dose TMP-SMX regimen

    Drug

    TMP \<15 mg/kg/day

Treatment groups

480 Participants
are divided into 1 treatment group
Group A: conventional-dose TMP-SMX regimen1 intervention

Trial outcomes

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.

Time frame
Up to 21 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Zhejiang Provincial Tongde Hospital

Collaborator

First Affiliated Hospital of Ningbo University

Collaborator

Source ClinicalTrials.gov

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