Pneumocystis Jiroveci PneumoniaPhase 3CAPSTONE-PJPNCT07152613
Corticosteroids for PJP in Non-HIV Immunocompromised Adults
A Phase 3 study testing Saline (0.9%, sterile, for infusion), Low Dose Corticosteroids and Moderate dose corticosteroids in people with Pneumocystis Jiroveci Pneumonia, run by Qingyuan Zhan.
Trial summary
Pneumocystis jirovecii pneumonia (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Jiroveci Pneumonia
- What is being tested?
- Saline (0.9%, sterile, for infusion), Low Dose Corticosteroids and Moderate dose corticosteroids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2025to 31 Dec 2027
- Phase
- Phase 3
- 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
Who may be able to join
- Age ≥ 18 years.
- Admission to the Intensive Care Unit (ICU).
- Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
- Meeting at least one of the major diagnostic criteria for severe pneumonia:
- Requirement for endotracheal intubation and mechanical ventilation;
- Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
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- Or simultaneously fulfilling three of the minor criteria:
- Respiratory rate ≥ 30 breaths/min;
- PaO₂/FiO₂ ≤ 250 mmHg;
- Multilobar infiltrates;
- Altered mental status and/or disorientation;
- Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L);
- Leukopenia (white blood cell count < 4 × 10⁹/L);
- Thrombocytopenia (platelet count < 100 × 10⁹/L);
- Hypothermia (core temperature < 36 °C);
- Hypotension (systolic blood pressure < 90 mmHg) requiring aggressive fluid resuscitation.
- Confirmed PJ etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for Pneumocystis jirovecii in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid).
- Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within < 72 hours.
- Signed informed consent.
Who cannot join
- Age < 18 years.
- Pregnant or breastfeeding women.
- HIV infection.
- No targeted PJP therapy administered or therapy not according to standard protocol.
- Diagnosis of PJP >7 days prior to MICU admission.
- Use of corticosteroids for PJP prior to MICU admission.
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- Requirement for high-dose baseline corticosteroid therapy for other conditions (prednisone ≥ 0.5 mg/kg/day or equivalent).
- Any contraindication to corticosteroid use as judged by the investigator (e.g., severe concurrent infectious disease, severe gastrointestinal bleeding).
- Discharge or death within 48 hours after intervention.
- Participation in other clinical studies or refusal to participate in this study.
About this study
Official title: An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Pneumocystis Jirovecii Pneumonia (PJP) in Non-HIV Immunocompromised Patients
Pneumocystis jirovecii pneumonia (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and society. To address this medical challenge, our institution is conducting a study aimed at lowering PJP-related mortality. Specifically, we are performing an adaptive, randomized, open-label controlled trial in patients with severe PJP. The primary objective of this study is to scientifically evaluate the efficacy and safety of adjunctive corticosteroids at different dosages, in addition to early standard supportive care, for reducing mortality in severe PJP
- Conditions
- Pneumocystis Jiroveci Pneumonia
- Being tested
- Saline (0.9%, sterile, for infusion), Low Dose Corticosteroids, Moderate dose corticosteroids
- Keywords
- community-acquired pneumonia, Pneumocystis jiroveci, non-HIV, corticosteroids
- Medical subject headings
- Pneumonia, Pneumocystis, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline (0.9%, sterile, for infusion)Drug
Saline for control
Low Dose CorticosteroidsDrug
Methylprednisolone 0.5mg/kg ivgtt qd
Moderate dose corticosteroidsDrug
Methylprednisolone 1.0mg/kg ivgtt qd
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Control Group Receives: Drug: Saline (0.9%, sterile, for infusion) |
| Low dose steroids | Experimental | Low dose steroids Receives: Drug: Low Dose Corticosteroids |
| Moderate dose steroids | Experimental | moderate dose steroids Receives: Drug: Moderate dose corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-days all cause mortality
28-days all cause mortality
Measured: 28 days from inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start8 Sep 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumocystis Jiroveci PneumoniaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingyuan Zhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingyuan Zhan, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152613
- Sponsor's protocol ID
- 2025-I2M-C&T-B-090B
- Acronym
- CAPSTONE-PJP
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Pneumocystis Jirovecii Pneumonia (PJP) in Non-HIV Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT07152613
- Acronym / sponsor ID
- CAPSTONE-PJP / 2025-I2M-C&T-B-090B
- Conditions
- Pneumocystis Jiroveci Pneumonia
- Keywords
- community-acquired pneumonia, Pneumocystis jiroveci, non-HIV, corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Qingyuan ZhanUniversity, hospital or other
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Sep 2025 (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 (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and society. To address this medical challenge, our institution is conducting a study aimed at lowering PJP-related mortality. Specifically, we are performing an adaptive, randomized, open-label controlled trial in patients with severe PJP. The primary objective of this study is to scientifically evaluate the efficacy and safety of adjunctive corticosteroids at different dosages, in addition to early standard supportive care, for reducing mortality in severe PJP
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Placebo comparator | Drug: Saline (0.9%, sterile, for infusion)Control Group |
| Low dose steroids | Experimental | Drug: Low Dose CorticosteroidsLow dose steroids |
| Moderate dose steroids | Experimental | Drug: Moderate dose corticosteroidsmoderate dose steroids |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years.
- Admission to the Intensive Care Unit (ICU).
- Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
- Requirement for endotracheal intubation and mechanical ventilation;
- Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
Key exclusion criteria (10 listed)
- Age < 18 years.
- Pregnant or breastfeeding women.
- HIV infection.
- No targeted PJP therapy administered or therapy not according to standard protocol.
- Diagnosis of PJP >7 days prior to MICU admission.
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 |
|---|---|---|
| Saline (0.9%, sterile, for infusion)Saline for control | Drug | Standard of Care |
| Low Dose CorticosteroidsMethylprednisolone 0.5mg/kg ivgtt qd | Drug | Low dose steroids |
| Moderate dose corticosteroidsMethylprednisolone 1.0mg/kg ivgtt qd | Drug | Moderate dose steroids |
Primary outcome
28-days all cause mortality
Time frame: 28 days from inclusion
28-days all cause mortality
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 9 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline (0.9%, sterile, for infusion), Low Dose Corticosteroids and Moderate dose corticosteroids in people with Pneumocystis Jiroveci Pneumonia, run by Qingyuan Zhan.
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 19 inclusion and 10 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 9 Sep 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-days all cause mortality (time frame: 28 days from inclusion). 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 9 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.