Status:
NOT_YET_RECRUITING
Corticosteroids for PJP in Non-HIV Immunocompromised Adults
Lead Sponsor:
Qingyuan Zhan
Conditions:
Pneumocystis Jiroveci Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 imp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT07152613
Start Date
September 8 2025
End Date
December 31 2027
Last Update
September 9 2025
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