Randomized Adaptive Platform Trial of Pathogen-Directed Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)

NCT07152587 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-I2M-C&T-B-090
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Severe Community-acquired Pneumonia (sCAP)

Keywords

community-acquired pneumonia; adaptive platform trial; pathogen directed; corticosteroids

Outcome Measures

Primary Outcomes (1)

• 28-day all cause mortality

  death at 28th day after inclusion

  28 days from inclusion

Study Arms (3)

Standard of Care

PLACEBO COMPARATOR

Receive Standard of care for SCAP, including antibiotics and respiratory support.

Drug: Saline (0.9% NaCl)

Low dose steroids

EXPERIMENTAL

Intervention: Receive 0.5mg/kg Methylprednisolone

Drug: Low dose steroids

Moderate dose steroids

EXPERIMENTAL

Intervention: Receive 1.0mg/kg Methylprednisolone

Drug: Moderate dose steroids

Interventions

Low dose steroids DRUG

Receive 0.5mg/kg Methylprednisolone

Low dose steroids

Moderate dose steroids DRUG

Receive 1.0mg/kg Methylprednisolone

Moderate dose steroids

Saline (0.9% NaCl) DRUG

Saline 100ml

Standard of Care

Eligibility Criteria

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

You may qualify if:

• Admission to ICU;
• Age ≥ 18 years;
• ICU length of stay ≤ 48 hours; ④ Meeting the IDSA/ATS diagnostic criteria for SCAP.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qingyuan Zhan: lead

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Steroids; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: September 3, 2025

Record last verified: 2025-08