An Open, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetics of ABCD for Invasive Candidiasis and Invasive Aspergillosis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set
研究概览
简要总结
This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.
详细描述
This study will evaluate the safety, efficacy and population pharmacokinetic characteristics of ABCD in the treatment of invasive candidiasis and invasive aspergillosis. About 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
- •Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
- •Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment.
- •Signed Informed Consent Form.
排除标准
- •Allergic to ABCD or azole antifungal drugs；
- •For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days;
- •For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days;
- •Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
- •Patients with a history of drug abuse or drug dependence;
- •Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
- •Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
- •Patients with abnormal liver function;
- •Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
- •Hypokalemia, which cannot be corrected before trial treatment;
- •Expected survival time is less than 2 months;
- •Patients with cardiac function of New York Heart Association（NYHA）class III/IV;
- •Positive for HIV antibody;
- •Pregnant or lactating women;
研究组 & 干预措施
Amphotericin B cholesteryl sulfate complex for injection(ABCD)
Patients with invasive candidiasis (IC) will only receive intravenous treatment with ABCD. ABCD will be administered once a day at a dose of 3-4 mg/kg.
Patients with invasive aspergillosis (IA) will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. ABCD dosing regimen will be the same as that for IC patients.
干预措施: Amphotericin B cholesteryl sulfate complex for injection(ABCD) (Drug)
结局指标
主要结局
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set
时间窗: 4-6 weeks
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set
时间窗: 4-6 weeks
Overall response success rate at the end of ABCD treatment, m ITT analysis set
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
时间窗: 4-6 weeks
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
次要结局
- Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.(4-6 weeks)
- The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set(4-6 weeks)
- 30-d all-cause mortality rate after starting treatment; mITT analysis set(30 days after starting treatment)