Severe Community-acquired Pneumonia (sCAP)Phase 2/3PANDA-SCAPNCT07152587
Randomized Adaptive Platform Trial of Pathogen-Directed Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)
A Phase 2/3 study testing Low dose steroids, Moderate dose steroids and Saline (0.9% NaCl) in people with Severe Community-acquired Pneumonia (sCAP), run by Qingyuan Zhan.
Trial summary
Severe community-acquired pneumonia (sCAP) has a high mortality rate of 25-50%. Excessive host inflammatory responses contribute to poor outcomes. Corticosteroid therapy may provide benefit; however, the optimal dosage remains unclear, and it is uncertain whether all etiologies (e.g., Pneumocystis jirovecii… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Community-acquired Pneumonia (sCAP)
- What is being tested?
- Low dose steroids, Moderate dose steroids and Saline (0.9% NaCl)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2025to 31 Dec 2035
- Phase
- Phase 2/3
- 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
- Admission to ICU;
- Age ≥ 18 years;
- ICU length of stay ≤ 48 hours; ④ Meeting the IDSA/ATS diagnostic criteria for SCAP.
Who cannot join
- Confirmed diagnosis of hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP);
- Expected death within 24 hours;
- Presence of septic shock prior to randomization; ④ History of allergy or contraindications to corticosteroids (e.g., active gastrointestinal bleeding, severe osteoporosis, uncontrolled hyperglycemia, bone marrow suppression);
- Active fungal (except Pneumocystis jirovecii), tuberculosis, or hepatitis infection;
- Receiving ongoing corticosteroid therapy at a dose equivalent to prednisone > 1 mg/kg/day due to underlying disease; ⑦ Participation in this trial within the past 90 days; ⑧ Refusal to sign informed consent.
About this study
Official title: Randomized, Embedded, Multifactorial, Adaptive Platform Trial of Pathogen-Directed Precision Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)
Severe community-acquired pneumonia (sCAP) has a high mortality rate of 25-50%. Excessive host inflammatory responses contribute to poor outcomes. Corticosteroid therapy may provide benefit; however, the optimal dosage remains unclear, and it is uncertain whether all etiologies (e.g., Pneumocystis jirovecii, adenovirus, influenza) of sCAP can benefit equally.
This study will first establish a comprehensive trial platform based on a prospective sCAP cohort, embedding a randomized, multifactorial, adaptive platform trial (APT). The response-adaptive design will increase the likelihood of patients being assigned to more effective treatment arms, while Bayesian statistical modeling will dynamically assess the efficacy of interventions, allowing early achievement of study endpoints.
Read more
At the starting stage, two pathogen-specific APTs will be conducted, focusing on adenovirus- and pneumocystis Jirovecii-induced sCAP. Patients admitted to the ICU with confirmed diagnoses of adenovirus or pneumocystis Jirovecii-associated sCAP will be randomized into a control group or one of two corticosteroid dosage groups. The primary endpoint will be 28-day all-cause mortality. Completion of these APTs will provide a theoretical basis for novel anti-inflammatory strategies in sCAP.
Moreover, this platform will serve as an essential research infrastructure for the efficient evaluation of new therapeutic options in the event of emerging or re-emerging respiratory pathogens causing sCAP in the future.
- Being tested
- Low dose steroids, Moderate dose steroids, Saline (0.9% NaCl)
- Keywords
- community-acquired pneumonia, adaptive platform trial, pathogen directed, corticosteroids
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose steroidsDrug
Receive 0.5mg/kg Methylprednisolone
Moderate dose steroidsDrug
Receive 1.0mg/kg Methylprednisolone
Saline (0.9% NaCl)Drug
Saline 100ml
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Placebo comparator | Receive Standard of care for SCAP, including antibiotics and respiratory support. Receives: Drug: Saline (0.9% NaCl) |
| Low dose steroids | Experimental | Intervention: Receive 0.5mg/kg Methylprednisolone Receives: Drug: Low dose steroids |
| Moderate dose steroids | Experimental | Intervention: Receive 1.0mg/kg Methylprednisolone Receives: Drug: Moderate dose steroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day all cause mortality
death at 28th day after inclusion
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 completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Community-acquired Pneumonia (sCAP)Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,500 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
- NCT07152587
- Sponsor's protocol ID
- 2025-I2M-C&T-B-090
- Acronym
- PANDA-SCAP
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Embedded, Multifactorial, Adaptive Platform Trial of Pathogen-Directed Precision Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)
- ClinicalTrials.gov ID
- NCT07152587
- Acronym / sponsor ID
- PANDA-SCAP / 2025-I2M-C&T-B-090
- Keywords
- community-acquired pneumonia, adaptive platform trial, pathogen directed, corticosteroids
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Qingyuan ZhanUniversity, hospital or other
- Study start
- 8 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (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.
Severe community-acquired pneumonia (sCAP) has a high mortality rate of 25-50%. Excessive host inflammatory responses contribute to poor outcomes. Corticosteroid therapy may provide benefit; however, the optimal dosage remains unclear, and it is uncertain whether all etiologies (e.g., Pneumocystis jirovecii, adenovirus, influenza) of sCAP can benefit equally.
This study will first establish a comprehensive trial platform based on a prospective sCAP cohort, embedding a randomized, multifactorial, adaptive platform trial (APT). The response-adaptive design will increase the likelihood of patients being assigned to more effective treatment arms, while Bayesian statistical modeling will dynamically assess the efficacy of interventions, allowing early achievement of study endpoints.
At the starting stage, two pathogen-specific APTs will be conducted, focusing on adenovirus- and pneumocystis Jirovecii-induced sCAP. Patients admitted to the ICU with confirmed diagnoses of adenovirus or pneumocystis Jirovecii-associated sCAP will be randomized into a control group or one of two corticosteroid dosage groups. The primary endpoint will be 28-day all-cause mortality. Completion of these APTs will provide a theoretical basis for novel anti-inflammatory strategies in sCAP.
Moreover, this platform will serve as an essential research infrastructure for the efficient evaluation of new therapeutic options in the event of emerging or re-emerging respiratory pathogens causing sCAP in the future.
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% NaCl)Receive Standard of care for SCAP, including antibiotics and respiratory support. |
| Low dose steroids | Experimental | Drug: Low dose steroidsIntervention: Receive 0.5mg/kg Methylprednisolone |
| Moderate dose steroids | Experimental | Drug: Moderate dose steroidsIntervention: Receive 1.0mg/kg Methylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to ICU;
Key exclusion criteria (5 listed)
- Confirmed diagnosis of hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP);
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 steroidsReceive 0.5mg/kg Methylprednisolone | Drug | Low dose steroids |
| Moderate dose steroidsReceive 1.0mg/kg Methylprednisolone | Drug | Moderate dose steroids |
| Saline (0.9% NaCl)Saline 100ml | Drug | Standard of Care |
Primary outcome
28-day all cause mortality
Time frame: 28 days from inclusion
death at 28th day after inclusion
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 3 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 2/3 study testing Low dose steroids, Moderate dose steroids and Saline (0.9% NaCl) in people with Severe Community-acquired Pneumonia (sCAP), 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 3 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 3 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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-day 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 3 Sep 2025.