An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Severe Adenovirus Community-Acquired Pneumonia in Adults
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 262
- 主要终点
- 28-day all cause mortality
研究概览
简要总结
Severe community-acquired pneumonia caused by adenovirus (hereafter referred to as severe adenovirus pneumonia) is one of the common forms of severe community-acquired pneumonia in immunocompetent adults. It predominantly affects young individuals, progresses rapidly, and is associated with a high incidence of respiratory failure and multiple organ dysfunction. At present, there is no effective antiviral therapy available in China, and the reported mortality rate ranges from 41.5% to 80%. How to effectively reduce the mortality of severe adenovirus pneumonia, on the basis of conventional supportive care, is crucial for improving the prognosis of critically ill patients and alleviating the burden on families and society. We are currently conducting an adaptive, randomized, open-label controlled trial aimed at reducing mortality in severe adenovirus pneumonia. The primary objective of this study is to evaluate the efficacy and safety of adjunctive corticosteroid therapy at different dosages, in addition to early standard supportive treatment, in lowering mortality among patients with severe adenovirus pneumonia.
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 adenovirus etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for adenovirus 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
- •Patients receiving vasopressor therapy for septic shock at the time of enrollment.
- •Terminally ill patients (expected survival <30 days, e.g., advanced malignancy).
- •Clinical history suggesting overt aspiration.
- •Documented active gastrointestinal bleeding.
- •Presence of cystic fibrosis, obstructive pneumonia, active influenza, pulmonary tuberculosis, or fungal infection.
- •Active viral hepatitis or active herpesvirus infection.
- •Bone marrow suppression or HIV infection.
- •Refusal of mechanical ventilation and endotracheal intubation.
- •Uncontrolled hyperglycemia (diabetic ketoacidosis with blood ketones >3 mmol/L, or hyperosmolar hyperglycemic state with blood glucose >33.3 mmol/L and elevated osmolality).
- •Known allergy to corticosteroids.
- •Patients requiring anti-inflammatory corticosteroids or replacement hydrocortisone for any reason, or those already receiving prednisone >15 mg/day (or equivalent dose of another corticosteroid).
- •Pregnant or breastfeeding women.
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
treated with low dose corticosteroids
干预措施: low dose Methylprednisolone (Drug)
Moderate dose steroids
treated with moderate dose corticosteroids
干预措施: Moderate dose Methylprednisolone (Drug)
结局指标
主要结局
28-day all cause mortality
时间窗: 28 days from inclusion
次要结局
未报告次要终点
研究者
Qingyuan Zhan
Director
China-Japan Friendship Hospital