Acute Respiratory FailurePhase 1/2NCT07357935
Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respiratory Failure Induced by Community-Acquired Pneumonia
A Phase 1/2 study testing Methylprednisolone in people with Acute Respiratory Failure and Community-Acquired Pneumonia, run by Qingyuan Zhan.
Trial summary
This is a prospective, multicenter, interventional cohort study aimed at constructing a high-quality, dynamic multimodal database for patients with acute respiratory failure caused by community-acquired pneumonia (CAP-ARF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Community-Acquired Pneumonia
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Oct 2028
- Phase
- Phase 1/2
- 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
Inclusion Criteria:1. Age ≥ 18 years. 2. Admitted to the Intensive Care Unit (ICU) within 48 hours. 3. Meet diagnostic criteria for bacterial community-acquired pneumonia (CAP). 4. Meet at least one severity criterion: a) Receiving mechanical ventilation for acute respiratory failure with PEEP ≥ 5 cmH2O; OR b) On high-flow oxygen with FiO2 ≥ 0.5 and PaO2/FiO2 ratio ≤ 250 mmHg; OR c) On a reservoir oxygen mask with PaO2 below the specified flow threshold (see protocol). 5. Signed informed consent.
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Exclusion Criteria: 1. Suspected aspiration pneumonia. 2. Invasive mechanical ventilation within 14 days prior to admission. 3. Diagnosis of hospital-acquired or ventilator-associated pneumonia (HAP/VAP). 4. Positive for influenza virus, active tuberculosis, or fungal infection (except Pneumocystis jirovecii). 5. Active viral hepatitis or herpesvirus infection. 6. Hypersensitivity to glucocorticoids, or contraindications as judged by the investigator (e.g., severe concurrent infections, active gastrointestinal hemorrhage). 7. High-dose glucocorticoid therapy (>1 mg/kg/day prednisone equivalent) within 30 days for underlying disease. 8. Death within 24 hours of ICU admission. 9. Pregnancy or lactation. 10. Participation in other interventional studies or refusal to participate.
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About this study
This is a prospective, multicenter, interventional cohort study aimed at constructing a high-quality, dynamic multimodal database for patients with acute respiratory failure caused by community-acquired pneumonia (CAP-ARF). The study focuses on bacterial CAP-ARF patients receiving standardized glucocorticoid therapy to investigate the heterogeneity of treatment responses under different etiologies and immune statuses. The goal is to provide a data foundation for precise immune stratification and identification of glucocorticoid-sensitive populations.
Read the detailed description
This study is part of the National Major Science and Technology Project for the Prevention and Control of Emerging and Major Infectious Diseases. It integrates existing multicenter cohorts (including healthy individuals, non-infectious ARF, mild CAP, and CAP-ARF patients) and establishes a prospective, standardized glucocorticoid intervention cohort for bacterial CAP-ARF. Eligible patients (age ≥18, admitted to ICU ≤48 hours, meeting bacterial pneumonia and severe ARF criteria) are treated with methylprednisolone based on initial oxygenation index (PFR ≤150 mmHg: 1 mg/kg/d; PFR >150 mmHg: 0.5 mg/kg/d). Dosing is adjusted at day 4 based on clinical response (improvement in oxygenation and SOFA score), with a total treatment duration of 7 days. Multimodal data-including clinical information, inflammatory/immune biomarkers, chest CT imaging, and multi-omics sequencing (transcriptomics, proteomics, metabolomics)-are collected at multiple timepoints (baseline, day 4, day 8). The database will support the analysis of immune-inflammatory profiles, identification of glucocorticoid-responsive subgroups, and development of precision intervention strategies for CAP-ARF.
- Being tested
- Methylprednisolone
- 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.
Also called Solu-Medrol
This is the core intervention. For detailed dosage, administration, and dose-adjustment strategy, please refer to the Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Methylprednisolone Intervention (Dose-Adjusted) | Experimental | All enrolled patients receive intravenous methylprednisolone (0.5-1 mg/kg/day, dissolved in 100ml normal saline, once daily) for a total of 7 days. The initial dose is determined by the oxygenation index (PFR) at enrollment:
* PFR ≤ 150 mmHg: Methylprednisolone 1 mg/kg/day.
* PFR > 150 mmHg: Methylprednisolone 0.5 mg/kg/day.
At day 4 (D4), the dose is halved if the patient shows a clinical response (defined as an improvement in the oxygenation index ≥20% AND a decrease in SOFA score ≥2 points); otherwise, the original dose is maintained. Methylprednisolone is discontinued upon death or transfer out of the ICU. All patients also receive standard care for bacterial CAP-ARF as determined by the treating physician. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day all-cause mortality
The proportion of participants who die from any cause within 90 days after enrollment.
Measured: At Day 90 (from enrollment)
28-day all-cause mortality
The proportion of participants who die from any cause within 28 days after enrollment.
Measured: : At Day 28 (from enrollment)
Secondary outcomes (2)
Incidence of glucocorticoid-related adverse events (AEs)
The occurrence of AEs known to be associated with glucocorticoid therapy, including but not limited to: secondary infection, hyperglycemia, myopathy/weakness, gastrointestinal bleeding, sodium/water retention, and inflammatory rebound.
Measured: From the first dose of methylprednisolone up to Day 28 (the end of the primary safety observation period).
Proportion of participants with glucocorticoid responsiveness at Day 4
The proportion of participants who meet the pre-defined criteria for glucocorticoid responsiveness at Day 4 (D4) after initiating treatment. Responsiveness is defined as: an improvement in the oxygenation index (PFR) by ≥20% AND a decrease in Sequential Organ Failure Assessment (SOFA) score by ≥2 points compared to baseline (D1).
Measured: At Day 4 (from enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingyuan Zhan
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Wuhan Metware Biotechnology Co., Ltd.
- Responsible party
- Sponsor-investigator, Qingyuan Zhan, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357935
- Sponsor's protocol ID
- 2025ZD01902401
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respiratory Failure Induced by Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT07357935
- Acronym / sponsor ID
- 2025ZD01902401
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qingyuan ZhanUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, Wuhan Metware Biotechnology Co., Ltd.
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 22 Jan 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.
This is a prospective, multicenter, interventional cohort study aimed at constructing a high-quality, dynamic multimodal database for patients with acute respiratory failure caused by community-acquired pneumonia (CAP-ARF). The study focuses on bacterial CAP-ARF patients receiving standardized glucocorticoid therapy to investigate the heterogeneity of treatment responses under different etiologies and immune statuses. The goal is to provide a data foundation for precise immune stratification and identification of glucocorticoid-sensitive populations.
Detailed description
This study is part of the National Major Science and Technology Project for the Prevention and Control of Emerging and Major Infectious Diseases. It integrates existing multicenter cohorts (including healthy individuals, non-infectious ARF, mild CAP, and CAP-ARF patients) and establishes a prospective, standardized glucocorticoid intervention cohort for bacterial CAP-ARF. Eligible patients (age ≥18, admitted to ICU ≤48 hours, meeting bacterial pneumonia and severe ARF criteria) are treated with methylprednisolone based on initial oxygenation index (PFR ≤150 mmHg: 1 mg/kg/d; PFR >150 mmHg: 0.5 mg/kg/d). Dosing is adjusted at day 4 based on clinical response (improvement in oxygenation and SOFA score), with a total treatment duration of 7 days. Multimodal data-including clinical information, inflammatory/immune biomarkers, chest CT imaging, and multi-omics sequencing (transcriptomics, proteomics, metabolomics)-are collected at multiple timepoints (baseline, day 4, day 8). The database will support the analysis of immune-inflammatory profiles, identification of glucocorticoid-responsive subgroups, and development of precision intervention strategies for CAP-ARF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized Methylprednisolone Intervention (Dose-Adjusted) | Experimental | Drug: MethylprednisoloneAll enrolled patients receive intravenous methylprednisolone (0.5-1 mg/kg/day, dissolved in 100ml normal saline, once daily) for a total of 7 days. The initial dose is determined by the oxygenation index (PFR) at enrollment: * PFR ≤ 150 mmHg: Methylprednisolone 1 mg/kg/day. * PFR > 150 mmHg: Methylprednisolone 0.5 mg/kg/day. At day 4 (D4), the dose is halved if the patient shows a clinical response (defined as an improvement in the oxygenation index ≥20% AND a decrease in SOFA score ≥2 points); otherwise, the original dose is maintained. Methylprednisolone is discontinued upon death or transfer out of the ICU. All patients also receive standard care for bacterial CAP-ARF as determined by the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MethylprednisoloneAlso: Solu-MedrolThis is the core intervention. For detailed dosage, administration, and dose-adjustment strategy, please refer to the Arm Description. | Drug | Standardized Methylprednisolone Intervention (Dose-Adjusted) |
Primary outcome
90-day all-cause mortality
Time frame: At Day 90 (from enrollment)
The proportion of participants who die from any cause within 90 days after enrollment.
28-day all-cause mortality
Time frame: : At Day 28 (from enrollment)
The proportion of participants who die from any cause within 28 days after enrollment.
2 secondary outcomes
Incidence of glucocorticoid-related adverse events (AEs)
Time frame: From the first dose of methylprednisolone up to Day 28 (the end of the primary safety observation period).
Proportion of participants with glucocorticoid responsiveness at Day 4
Time frame: At Day 4 (from enrollment)
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 22 Jan 2026.
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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 1/2 study testing Methylprednisolone in people with Acute Respiratory Failure and Community-Acquired 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?
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 22 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
90-day all-cause mortality (time frame: At Day 90 (from enrollment)). The study lists 2 primary outcomes in all. 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 22 Jan 2026.