Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)
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 serious Candida infection. 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
- •Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection.
- •Male or female ≥ 16 years of age.
- •Expected hospitalization for at least fourteen (14) 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
干预措施: Active anidulafungin (Drug)
Caspofungin arm
干预措施: Active Caspofungin (Drug)
结局指标
主要结局
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)
时间窗: End of Treatment (Day 14 to Day 42)
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
次要结局
- Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit(2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT))
- Percentage of Participants With Response Based on Clinical Cure and Microbiological Success(EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT))
- Percentage of Participants With Clinical Response(Day 10)
- Percentage of Participants With Relapse(2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT))
- Percentage of Participants With New Infection(2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT))
- Time to Negative Blood Culture(Baseline up to 6-week follow-up (6 weeks after EOT))
- Percentage of Participants With All-cause Mortality(Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT))
- Time to Death(Baseline up to 6-week follow-up (6 weeks after EOT))