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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Placebo Comparator | Control Group |
|
| Low dose steroids | Experimental | Low dose steroids |
|
| Moderate dose steroids | Experimental | moderate dose steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline (0.9%, sterile, for infusion) | Drug | Saline for control |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 28-days all cause mortality | 28-days all cause mortality | 28 days from inclusion |
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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:
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| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Low Dose Corticosteroids |
| Drug |
Methylprednisolone 0.5mg/kg ivgtt qd |
|
| Moderate dose corticosteroids | Drug | Methylprednisolone 1.0mg/kg ivgtt qd |
|
| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017714 | Community-Acquired Infections |
| D017670 |
| Sodium Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |