Status:
NOT_YET_RECRUITING
Randomized Adaptive Platform Trial of Pathogen-Directed Anti-inflammatory Therapy in Severe Community-Acquired Pneumonia(Core Protocal)
Lead Sponsor:
Qingyuan Zhan
Conditions:
Severe Community-acquired Pneumonia (sCAP)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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, ...
Eligibility Criteria
Inclusion
- Admission to ICU;
- Age ≥ 18 years;
- ICU length of stay ≤ 48 hours; ④ Meeting the IDSA/ATS diagnostic criteria for SCAP.
Exclusion
- 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.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT07152587
Start Date
September 8 2025
End Date
December 31 2035
Last Update
September 3 2025
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