NCT07152613

Corticosteroids for PJP in Non-HIV Immunocompromised Adults

An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Pneumocystis Jirovecii Pneumonia (PJP) in Non-HIV Immunocompromised Patients

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Qingyuan Zhan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pneumocystis jirovecii pneumonia (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and society. To address this medical challenge, our institution is conducting a study aimed at lowering PJP-related mortality. Specifically, we are performing an adaptive, randomized, open-label controlled trial in patients with severe PJP. The primary objective of this study is to scientifically evaluate the efficacy and safety of adjunctive corticosteroids at different dosages, in addition to early standard supportive care, for reducing mortality in severe PJP

Conditions

• Pneumocystis Jiroveci Pneumonia

Interventions

Type	Name	Description
DRUG	Saline (0.9%, sterile, for infusion)	Saline for control
DRUG	Low Dose Corticosteroids	Methylprednisolone 0.5mg/kg ivgtt qd
DRUG	Moderate dose corticosteroids	Methylprednisolone 1.0mg/kg ivgtt qd

Timeline

• Start date: 2025-09-08
• Primary completion: 2027-06-30
• Completion: 2027-12-31
• First posted: 2025-09-03
• Last updated: 2025-09-09