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NCT07152587: PANDA-SCAP

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

Not yet recruiting Phase 2, PHASE3 Last updated 3 September 2025
What this trial tests

Phase 2, PHASE3 trial testing Low dose steroids in Severe Community-acquired Pneumonia (sCAP) in 1,500 participants. Not yet recruiting.

Timeline
8 September 2025
Primary endpoint
31 December 2035
31 December 2035

Quick facts

Lead sponsorQingyuan Zhan
PhasePhase 2, PHASE3
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment1,500
Start date8 September 2025
Primary completion31 December 2035
Estimated completion31 December 2035

Drugs / interventions tested

Conditions studied

Sponsor

Qingyuan Zhan — full company profile →

Who can join

18 and older, any sex, with Severe Community-acquired Pneumonia (sCAP). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Trials by the same sponsor.

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