A Prospective Randomized Controlled Study to Compare Efficacy of Caspofungin Combined With Trimethoprim-sulfamethoxazole Versus Trimethoprim/Sulfamethoxazole as First-line Therapy in Non-HIV Patients With Severe Pneumocystis Pneumonia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- mortality to day 28
研究概览
简要总结
This is a prospective, randomized clinical trial. During the study, non-HIV patients who are admitted to ICU due to Pneumocystic pneumonia (PCP) and have not received anti-PCP therapy or have received therapy less than 48hrs will be randomized (1:1) to received caspofungin combined with trimethoprim-sulfamethoxazole or trimethoprim-sulfamethoxazole alone.
The aim of this study is to compare the effectiveness of caspofungin combined with trimethoprim-sulfamethoxazole with that of conventional therapy (trimethoprim-sulfamethoxazole alone) as first-line therapy in the treatment of severe Pneumocystis pneumonia (PCP) in non-HIV patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Non-HIV immunosuppressed patients admitted to the ICU
- •confirmed or suspect PCP
- •Not receiving anti-PCP treatment or anti-PCP treatment < 48 hours
排除标准
- •Age less than 18 years old
- •Known pregnancy
- •allergy to TMP/SMZ or caspofungin
- •Decision to withhold life-sustaining treatment
- •Patients with advanced pulmonary fibrosis
- •severe liver dysfunction(Child-Pugh C )
研究组 & 干预措施
CAS with TMP/SMZ
干预措施: caspofungin (Drug)
CAS with TMP/SMZ
干预措施: TMP/SMZ(trimethoprim/sulfisoxazole) (Drug)
CAS with TMP/SMZ
干预措施: Methylprednisolone (Drug)
TMP/SMZ
干预措施: TMP/SMZ(trimethoprim/sulfisoxazole) (Drug)
TMP/SMZ
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
mortality to day 28
时间窗: 28 days after randomization
The percentage of subjects death at study day 28. Those subjects discharged from ICU prior to day 28 were counted as alive at day 28
次要结局
- ICU Free Days to day 28(28 days after randomization)
- ICU mortality(through ICU discharge, an average of 14 days)
- hospital mortality(through hospital discharge, an average of 28 days)
- SOFA(day3, 7, 21 after randomization)
- BALF cytokines level on day3, 7, 21(day3, 7, 21 after randomization)
- adverse events(till 21 days after randomization)
- serious adverse events(till 21 days after randomization)
- Mean Ventilator Free Days to day 28(28 days after randomization)
- PO2/FiO2 on day 7, 21(day 7, 21 after randomization)
- serum (1,3)-β-D gluca level on day 3, 7, 21(day3, 7, 21 after randomization)
- PCP-DNA negative conversion rate in alveolar lavage fluid on day 7 after randomization(day 7 after randomization)
研究者
Bin Du
Director
Peking Union Medical College Hospital