Pneumocystis Jirovecii Pneumonia in Non-HIV PatientsNCT07690410
TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
An observational study of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
- What is being tested?
- low-dose TMP-SMX regimen
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Being tested
- low-dose TMP-SMX regimen
- Keywords
- Trimethoprim-Sulfamethoxazole, Prospective Studies, Multicenter Study, Pneumocystis jirovecii, Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose TMP-SMX regimenDrug
TMP <15 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| conventional-dose TMP-SMX regimen | TMP 15-20 mg/kg/day Receives: Drug: low-dose TMP-SMX regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis Jirovecii Pneumonia in Non-HIV PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Zhejiang Provincial Tongde Hospital, First Affiliated Hospital of Ningbo University
- Responsible party
- Sponsor
- Investigators
- Yangmin Hu, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690410
- Sponsor's protocol ID
- 2026-0430
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TMP-SMX for Non-HIV-Related PCP: A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07690410
- Acronym / sponsor ID
- 2026-0430
- Keywords
- Trimethoprim-Sulfamethoxazole, Prospective Studies, Multicenter Study, Pneumocystis jirovecii, Pneumonia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Zhejiang Provincial Tongde Hospital, First Affiliated Hospital of Ningbo University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| conventional-dose TMP-SMX regimen | – | Drug: low-dose TMP-SMX regimenTMP 15-20 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose TMP-SMX regimenTMP <15 mg/kg/day | Drug | conventional-dose TMP-SMX regimen |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
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Corticosteroids for PJP in Non-HIV Immunocompromised Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yangmin Hu principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumocystis Jirovecii Pneumonia in Non-HIV Patients, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yangmin Hu (+86 057187783891, zrhym@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure at Day 21 (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.