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Corticosteroids for PJP in Non-HIV Immunocompromised Adults

NCT07152613 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-09-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Qingyuan Zhan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2027-06-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07152613 on ClinicalTrials.gov