A Clinical Study on the Efficacy and Safety of Amphotericin B Cholesteryl Sulfate Complex for Injection in the Empirical First-line Treatment of Patients With Invasive Fungal Diseases
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 125
- 主要终点
- Treatment is effective
研究概览
简要总结
This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years old, gender is not limited;
- •Patients with hematologic malignancies such as leukemia and lymphoma who have undergone chemotherapy or hematopoietic stem cell transplantation;
- •Peripheral blood absolute neutrophil count (ANC) < 0.5×109/L, or expected ANC < 0.5×109/L after 48 h;
- •Within 48 hours before the screening, at least 2 oral temperature measurements (with an interval of more than 30 minutes) ≥ 38.3°C (axillary temperature≥38.0°C), or ≥ 38°C (axillary temperature≥37.7°C) for more than 1h;
- •Received broad-spectrum antimicrobial therapy for at least 96 hours before screening but still had recurrent or persistent fever and suspected fungal infection;
- •The patient or his/her legal representative signs the informed consent form.
排除标准
- •Those who are allergic to amphotericin class B drugs or any component of the cholesterol-sulfate complex;
- •Patients with clinical suspicion of invasive fungal disease who have received antifungal therapy;
- •Patients with clinically diagnosed or confirmed invasive fungal disease (IFD) during the screening period;
- •Patients with abnormal liver function, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 5 times the upper limit of normal (ULN), or ALT or AST > 3 times ULN and total bilirubin > 1.5 times ULN;
- •Patients with reduced renal function, who need or are currently undergoing hemodialysis or peritoneal dialysis;
- •Clinically significant hypokalemia (defined as serum potassium < 3.2 mmol/L, or blood potassium lower than the lower limit of normal while receiving digitalis therapy), and hypokalemia cannot be corrected before starting trial treatment;
- •Expected survival time< 3 months;
- •Pregnant women, lactating women, or women of childbearing age who have not taken contraceptive measures and are planning to become pregnant;
- •Other investigators believe that it is not appropriate to participate in clinical trials.
研究组 & 干预措施
Amphotericin B cholesterol-sulfate complex (ABCD)
Investigational drug: Amphotericin B cholesterol-sulfate complex (ABCD) at the same time as a treatment for underlying disease.
Dosage: According to the patient's condition and the investigator's judgment, the initial dose of ABCD can be 0.5-1.0mg/kg/d, and the dose can be increased daily according to the situation, and the therapeutic dose can be increased to 3.0-4.0mg/kg/d on the third day.
Course of treatment: ≥ 14 days (whether to continue to receive trial drug treatment after 14 days is decided by the investigator according to the patient's condition).
干预措施: Amphotericin B cholesterol-sulfate complex for injection (Drug)
结局指标
主要结局
Treatment is effective
时间窗: 12 months
A patient is considered successful if they meet the following five criteria: Starting antifungal treatment until no new fungal infections occur within 7 days after discontinuation of medication; Patient survival within 7 days after discontinuation of treatment; During the treatment period, the drug was not stopped due to side effects or lack of efficacy; After starting antifungal therapy, patients experience fever reduction during neutropenia (defined as body temperature\<38 ℃ for more than 48 hours); Invasive fungal diseases diagnosed or clinically diagnosed (baseline fungal infection refers to fungal infection confirmed within 24-48 hours after initiation of antifungal treatment) achieve complete or partial efficacy at the end of treatment. Refer to the "Diagnostic Criteria and Treatment Principles for Invasive Fungal Disease in Patients with Hematological Diseases/Malignant Tumors (Sixth Revised Edition)" for the evaluation criteria for the treatment efficacy.
次要结局
- Incidence of the single index in the five criteria of treatment success(12 months)
- Completion rate of ABCD treatment for at least 14 days(12 months)