Antifungal Treatment of Cryptococcal Meningitis
试验速览
- 阶段
- 3 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects died at weeks 48
研究概览
简要总结
Cryptococcal meningitis (CM) is one of the leading opportunistic infections and one of the most common causes of death in AIDS patients.
Amphotericin B (AmB) is the corner stone in CM treatment. The effect of AmB was dose-dependent. Recent retrospective study indicated that longer duration rather than higher dose of AmB is necessary to reduce the mortality of CM. We aimed to explore the efficacy and safety of small dose but longer duration of AmB for the treatment of HIV-associated CM.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV infection
- •Naive to antiretroviral therapy
- •Cryptococcal antigen, smear or culture positive in cerebrospinal fluid
- •Agree to participate the study
排除标准
- •Having receiving antifungal treatment for ≥3 days
- •ALT or AST > 5* upper limit of detection (ULD), or neutrophil< 0.5*10E9 cells/L, or hemoglobin < 90g/L or platelet <50*10E9/L or serum creatinine > ULD
- •Pregnancy or breastfeeding
- •Concomitant medications that are contraindicated with any research drug
- •Any other contraindications for using amphotericin B or 5FC
- •Inability to follow-up as accessed by the investigator
研究组 & 干预措施
Trial
Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
干预措施: Amphotericin B (Drug)
Trial
Amphotericin B 0.5 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 4 weeks
干预措施: Flucytosine (Drug)
Control
Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
干预措施: Amphotericin B (Drug)
Control
Amphotericin B 0.7 mg/kg IVGTT QD + Flucytosine 100mg/kg PO QD for 2 weeks
干预措施: Flucytosine (Drug)
结局指标
主要结局
Number of subjects died at weeks 48
时间窗: 48 weeks after randomization
Mortality in intent to treat population
次要结局
- Number of subjects with disability at weeks 48(48 weeks after randomization)
- Number of subjects with CSF culture positive for Cryptococcus at weeks 2(2 weeks after randomization)
研究者
Jun Chen
Assistant of the department
Shanghai Public Health Clinical Center