Corticosteroids for PJP in Non-HIV Immunocompromised Adults

NCT07152613 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025-I2M-C&T-B-090B
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

community-acquired pneumonia; Pneumocystis jiroveci; non-HIV; corticosteroids

Outcome Measures

Primary Outcomes (1)

• 28-days all cause mortality

  28-days all cause mortality

  28 days from inclusion

Study Arms (3)

Standard of Care

PLACEBO COMPARATOR

Control Group

Drug: Saline (0.9%, sterile, for infusion)

Low dose steroids

EXPERIMENTAL

Low dose steroids

Drug: Low Dose Corticosteroids

Moderate dose steroids

EXPERIMENTAL

moderate dose steroids

Drug: Moderate dose corticosteroids

Interventions

Saline (0.9%, sterile, for infusion) DRUG

Saline for control

Standard of Care

Low Dose Corticosteroids DRUG

Methylprednisolone 0.5mg/kg ivgtt qd

Low dose steroids

Moderate dose corticosteroids DRUG

Methylprednisolone 1.0mg/kg ivgtt qd

Moderate dose steroids

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Admission to the Intensive Care Unit (ICU).
• Meeting the diagnostic criteria for community-acquired pneumonia (CAP).
• Meeting at least one of the major diagnostic criteria for severe pneumonia:
• (i) Requirement for endotracheal intubation and mechanical ventilation;
• (ii) Septic shock requiring vasopressor therapy after adequate fluid resuscitation.
• Or simultaneously fulfilling three of the minor criteria:
• (i) Respiratory rate ≥ 30 breaths/min;
• (ii) PaO₂/FiO₂ ≤ 250 mmHg;
• (iii) Multilobar infiltrates;
• (iv) Altered mental status and/or disorientation;
• (v) Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L);
• (vi) Leukopenia (white blood cell count \< 4 × 10⁹/L);
• (vii) Thrombocytopenia (platelet count \< 100 × 10⁹/L);
• (viii) Hypothermia (core temperature \< 36 °C);

You may not qualify if:

• Age \< 18 years.
• Pregnant or breastfeeding women.
• HIV infection.
• No targeted PJP therapy administered or therapy not according to standard protocol.
• Diagnosis of PJP \>7 days prior to MICU admission.
• Use of corticosteroids for PJP prior to MICU admission.
• Requirement for high-dose baseline corticosteroid therapy for other conditions (prednisone ≥ 0.5 mg/kg/day or equivalent).
• Any contraindication to corticosteroid use as judged by the investigator (e.g., severe concurrent infectious disease, severe gastrointestinal bleeding).
• Discharge or death within 48 hours after intervention.
• Participation in other clinical studies or refusal to participate in this study.

Sponsors & Collaborators

• Qingyuan Zhan: lead

MeSH Terms

Conditions

Pneumonia, Pneumocystis; Community-Acquired Pneumonia

Interventions

Sodium Chloride; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• 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): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09