Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
研究概览
简要总结
The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Male or female subjects > or equal to 18 years of age.
- •Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
- •Subjects who received no more than one prior dose of an echinocandin or polyene.
排除标准
- •Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
- •Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
- •Subjects with infected prosthetic devices which cannot be removed within 24 hours
研究组 & 干预措施
1.
Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
干预措施: Eraxis (anidulafungin) (Drug)
1.
Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
干预措施: Diflucan (fluconazole) (Drug)
1.
Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
干预措施: Vfend (voriconazole) (Drug)
结局指标
主要结局
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
时间窗: End of Treatment (Day 5 up to Day 42)
Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species \[spp\]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
次要结局
- Number of Participants With Clinical Response at EOT(End of Treatment (Day 5 up to Day 42))
- Number of Participants With Microbiological Response at EOT(End of Treatment (Day 5 up to Day 42))
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)(End of Intravenous treatment (Day 5 up to Day 28))
- Number of Participants With Clinical Response at EOIV(End of Intravenous treatment (Day 5 up to Day 28))
- Number of Participants With Microbiological Response at EOIV(End of Intravenous treatment (Day 5 up to Day 28))
- Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up(Week 2 Follow-up)
- Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up(Week 2 follow-up)
- Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up(Week 2 Follow-up)
- Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])(Week 6 Follow-up (EOS))
- Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)(Week 6 follow-up (EOS))
- Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)(Week 6 Follow-up (EOS))
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline(End of Treatment (Day 5 up to Day 42))
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline(End of Intravenous treatment (Day 5 up to Day 28))
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline(Week 2 Follow-up)
- Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline(Week 6 Follow-up (EOS))
- Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species(Baseline (Day 1) up to Week 6 Follow-up (EOS))
- Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)(Baseline up to 6 Week Follow-up (EOS))
- Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)(Baseline up to 6 Week Follow-up (EOS))
- Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)(Baseline up to End of Intravenous treatment (Day 5 up to Day 28))
- Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)(Baseline up to End of Treatment (Day 5 up to Day 42))
- Number of Participants Per Specified Cause of Death(Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later))
- Number of Participants With Non-serious and Serious Adverse Events(Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later))
- Number of Participants Who Died(Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later))