A PROSPECTIVE RANDOMIZED, DOUBLE-BLIND, COMPARATIVE, MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF NYSTATIN AND AMPHOTERICIN B FOR EMPIRIC ANTIFUNGAL TREATMENT IN NEUTROPENIC PATIENTS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 118
研究概览
简要总结
RATIONALE: Antifungal therapy with liposomal nystatin may reduce fever and neutropenia in patients undergoing treatment for hematologic cancer. It is not yet known whether liposomal nystatin is more effective than standard amphotericin B in treating patients with fever and neutropenia who are receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.
PURPOSE: Randomized phase III trial to study the effectiveness of liposomal nystatin compared with standard amphotericin B to treat fever and neutropenia in patients receiving chemotherapy for hematologic cancer or bone marrow transplantation for leukemia.
详细描述
OBJECTIVES: I. Compare the efficacy of liposomal nystatin vs standard amphotericin B for the empiric treatment of persistent febrile neutropenic patients. II. Compare the incidence of drug-related toxicity or impairment and infusion-related toxicity in patients treated with liposomal nystatin vs standard amphotericin B. III. Determine the pharmacokinetics of liposomal nystatin.
OUTLINE: Randomized, double-blind study. Arm I: Antifungal Therapy. Liposomal Nystatin. Arm II: Antifungal Therapy. Amphotericin B, NSC-527017.
PROJECTED ACCRUAL: 350 evaluable patients will be studied in this multicenter trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Persistent febrile neutropenia associated with 1 of the following within 3 months prior to entry: Cytotoxic chemotherapy Bone marrow transplantation Neutropenia defined as either: ANC no greater than 500/mm3 ANC no greater than 1,000/mm3 and expected to decrease to 500/mm3 or less within 2 days after entry Persistent continuous or spiking fever of at least 38 C No association with administration of pyrogenic substances No response to at least 72 hours of empiric, broad-spectrum antibacterial therapy No microbiologically documented source of infection At least 30 days since documented invasive fungal infection
- •PATIENT CHARACTERISTICS: Age: 2 and over Performance status: Not specified Life expectancy: At least 28 days Hematopoietic: Not specified Hepatic: No grade 2 or greater hepatic impairment Renal: No grade 2 or greater renal impairment No peritoneal dialysis or hemodialysis Other: No history of severe allergic reaction to polyene antifungal agent No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women during and for 3 months after study
- •PRIOR CONCURRENT THERAPY: At least 2 weeks since polyene antifungal therapy Concurrent oral prophylactic antifungal therapy with an azole antifungal agent (e.g., fluconazole, itraconazole) allowed if patient remains febrile No concurrent azole therapy At least 30 days since other investigational drug or device except investigational formulation of amphotericin B
排除标准
- 未提供