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Not yet recruiting NCT07152613

Corticosteroids for PJP in Non-HIV Immunocompromised Adults

Phase III Interventional Pneumocystis Jiroveci Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline (0.9%, sterile, for infusion), Low Dose Corticosteroids, Moderate dose corticosteroids.
Who it may be relevant to
Registry conditions: Pneumocystis Jiroveci Pneumonia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • 28-days all cause mortality [Time frame: 28 days from inclusion]

Eligibility criteria

Inclusion criteria

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);

(ix) Hypotension (systolic blood pressure < 90 mmHg) requiring aggressive fluid resuscitation.

Confirmed PJ etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for Pneumocystis jirovecii in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid).

Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within < 72 hours.

Signed informed consent.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07152613 · 2025-I2M-C&T-B-090B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗