Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respi… (NCT07357935) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respiratory Failure Induced by Community-Acquired Pneumonia
500 participantsStarted 2026-02-01
Plain-language 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). 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.