Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Global Response at End of Intravenous Treatment (EOIVT)
研究概览
简要总结
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dysfunctional immune system (reduced neutrophils).
- •Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
- •Male of female ≥16 years of age.
- •Expected hospitalization for at least ten (10) days.
排除标准
- •Pregnancy or breast feeding or planning to become pregnant during the study.
- •Recent treatment with one of the study drugs over the last 30 days.
- •Allergy to either study drug or to this class of drugs.
- •Significant liver dysfunction.
- •Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
研究组 & 干预措施
Anidulafungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
干预措施: Active Anidulafungin (Drug)
Caspofungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
干预措施: Active Caspofungin (Drug)
结局指标
主要结局
Global Response at End of Intravenous Treatment (EOIVT)
时间窗: Day 10 up to Day 42
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
次要结局
- Number of Participants With New Infections(2 and 6 weeks post treatment)
- Global Response at End of Treatment (EOT)(Day 14 up to Day 56)
- Global Response at 2-Week Follow-Up Visit(2 weeks post treatment)
- Global Response at 6-Week Follow-Up Visit(6 weeks post treatment)
- Response Based on Clinical Cure and Microbiological Success at EOIVT(Day 10 up to Day 42)
- Response Based on Clinical Cure and Microbiological Success at EOT(Day 14 up to Day 56)
- Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit(2 weeks post treatment)
- Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit(6 weeks post treatment)
- Clinical Response at Day 10(Day 10)
- Number of Participants With Recurrence(2 and 6 weeks post treatment)
- Time to First Negative Blood Culture for Candida Species(Baseline up to Day 56)
- Time to Death(Day 1 up to Day 98)
- All-Cause Mortality(Baseline up to 6 weeks post treatment)