An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Pneumocystis Jirovecii Pneumonia (PJP) in Non-HIV Immunocompromised Patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 主要终点
- 28-days all cause mortality
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard of Care
Control Group
干预措施: Saline (0.9%, sterile, for infusion) (Drug)
Low dose steroids
Low dose steroids
干预措施: Low Dose Corticosteroids (Drug)
Moderate dose steroids
moderate dose steroids
干预措施: Moderate dose corticosteroids (Drug)
结局指标
主要结局
28-days all cause mortality
时间窗: 28 days from inclusion
28-days all cause mortality
次要结局
未报告次要终点
研究者
Qingyuan Zhan
Director
China-Japan Friendship Hospital