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NCT Number: NCT07152613

Corticosteroids for PJP in Non-HIV Immunocompromised Adults

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saline (0.9%, sterile, for infusion)

Drug

Saline for control

Low Dose Corticosteroids

Drug

Methylprednisolone 0.5mg/kg ivgtt qd

Moderate dose corticosteroids

Drug

Methylprednisolone 1.0mg/kg ivgtt qd

Primary outcomes

  1. 28-days all cause mortality

    Time frame: 28 days from inclusion

    28-days all cause mortality

Sponsors and collaborators

Lead sponsor

Qingyuan Zhan

Other

Registry information

Official study title

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

Acronym: CAPSTONE-PJP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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