NCT00106288已完成3 期
A Multicenter, Double Blind, Comparative, Randomized Study to Evaluate the Efficacy and Safety of Micafungin (FK463) Versus Liposomal Amphotericin B (AmBisome) in the Treatment of Invasive Candidiasis and Candidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 637
- 主要终点
- Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of micafungin (FK463) versus liposomal amphotericin B (AmBisome) in treating neutropenic and non-neutropenic patients with confirmed invasive candidiasis or candidemia. Enrollment will include adult and pediatric patients.
详细描述
A phase III, multicenter, double-blind, comparative, parallel, randomized study. Enrollment will include adult and pediatric patients. The adult population is sized to test for non-inferiority. For the pediatric population, descriptive analyses are planned.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients either non-neutropenic with absolute neutrophil counts >= 500 cells/mm3 or neutropenic with absolute neutrophil counts < 500 cells/mm3 must have:
- •Candidemia or invasive candidiasis,
- •Confirmation and typical clinical signs and symptoms by fungal culture and/or histology,
- •Positive culture obtained no more than four days prior to the first dose of study medication.
排除标准
- •Patient is pregnant or nursing
- •Patients with evidence of liver disease as defined by: a) SGOT/AST or SGPT/ALT > 10 times the upper limit of normal (ULN); or b) Total bilirubin > 5 times ULN.
- •Patients whose sole diagnosis is oropharyngeal and/or esophageal candidiasis and/or with positive cultures of urine specimens, sputum specimens, bronchoalveolar-lavage specimens or samples from indwelling drains.
- •Patients who have received prophylactic/empiric therapy with azoles or conventional amphotericin B for more than three days within one week prior to enrollment. Neutropenic patients, however, may have received prophylactic azoles without time restrictions.
研究组 & 干预措施
1
Experimental
干预措施: Micafungin (Drug)
2
Active Comparator
干预措施: Liposomal Amphotericin B (Drug)
结局指标
主要结局
Investigator's assessment of overall treatment success. Success is defined as clinical (complete or partial) and mycological (eradication or presumed eradication) response at the End of Therapy.
时间窗: 6 and 12 weeks post treatment
次要结局
- Clinical response (complete, partial, stabilization, progression) during the treatment period and the post-treatment period(During the 2 to 8 week treatment period and the 12 week post treatment followup period)
- Mycological response (eradication, presumed eradication, persistence) during the treatment period and the post-treatment period(During the 2 to 8 week treatment period and the 12 week post treatment followup period)
- Patient survival at the End of Therapy and at the End of Study(End of the 2 to 8 week treatment period and end of the 12 week post treatment followup period)
- Incidence of acute infusion related reactions as pre-defined(During the 2 to 8 week treatment period)
- Overall incidence of Adverse Events (AE)(Throughout study and post treatment followup period)
- Overall incidence of emergent and recurrent fungal infections at the End of Study(End of the 12 week post treatment followup peroid)
- Independent Efficacy Review Committee's assessment of overall treatment success(Prior to database lock)
- Peak change of estimated glomerular filtration rate during the treatment period compared to Baseline(During the 2 to 8 week treatment period)
研究者
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