Early Inflammatory-Immune Stratification and Precision Glucocorticoid Intervention in Acute Respiratory Failure Induced by Community-Acquired Pneumonia

NCT07357935 | Not Yet Recruiting Phase 1

• 1 other identifier: 2025ZD01902401
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Respiratory Failure; Community-Acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

• 90-day all-cause mortality

  The proportion of participants who die from any cause within 90 days after enrollment.

  At Day 90 (from enrollment)

• 28-day all-cause mortality

  The proportion of participants who die from any cause within 28 days after enrollment.

  : At Day 28 (from enrollment)

Secondary Outcomes (2)

• Incidence of glucocorticoid-related adverse events (AEs)

  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

  At Day 4 (from enrollment)

Study Arms (1)

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.

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

This is the core intervention. For detailed dosage, administration, and dose-adjustment strategy, please refer to the Arm Description.

Also known as: Solu-Medrol

Standardized Methylprednisolone Intervention (Dose-Adjusted)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Qingyuan Zhan: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Wuhan Metware Biotechnology Co., Ltd.: collaborator

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Methylprednisolone; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01