NCT01202253已完成不适用
A Study To Describe The Early Clinical Experience With Anidulafungin In Patients With Liver Disease At King's College Hospital NHS Trust, London
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Favorable Outcome
研究概览
简要总结
The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.
详细描述
All subjects that have been treated with Anidulafungin according to its licence during the period of July 2009 and September 2010 will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th September
- •Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period
排除标准
- •Patients who participated in any interventional clinical trial during this episode of sepsis.
- •Patients who received anidulafungin for infection prophylaxis
研究组 & 干预措施
Anidulafungin
干预措施: anidulafungin (Drug)
结局指标
主要结局
Percentage of Participants With Favorable Outcome
时间窗: Day 28 post-treatment
Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.
次要结局
- Percentage of Participants With Prior Colonization With Candida by Colonization Index(Baseline)
- Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index(Baseline)
- Percentage of Participants With Unfavorable Outcome(Day 28 post-treatment)
- Percentage of Participants Who Died Due to All Causes(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Death Unrelated to Fungal Infection(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Oral Antifungal Started to Complete Therapy(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results(Baseline up to Day 28 post-treatment)
- Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU)(Baseline)
- Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy(Baseline)
- Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy(Baseline)
- Number of Participants With Infection Sites as Per Microbiological Analysis(Baseline)
- Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan(Baseline)
- Infecting Organisms by Species(Baseline up to Day 14 post-treatment)
- Percentage of Participants With Prior Colonization With Candida by Species(Baseline)
- Percentage of Participants With Death Attributable to Fungal Infection(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Favorable Clinical Response(Day 28 post-treatment)
- Duration of Stay at Liver Intensive Therapy Unit (LITU)(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy(Baseline)
- Percentage of Participants With Lack of Clinical Response(Day 28 post-treatment)
- Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy(Baseline)
- Percentage of Participants With Concomitant Bacterial or Viral Infection(Baseline)
- Dose Changes for Immunosuppressant Drugs(Baseline up to Day 28 post-treatment)
- Percentage of Participants Requiring Change or Additional Antifungal Therapy(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Documented Eradication of Infecting Species(Baseline)
- Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy(Day 28 post-treatment)
- Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy(Baseline up to Day 28 post-treatment)
- Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3(Baseline)
- Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start(Baseline)
- Number of Participants Who Received Water-based and Ethanol-based Formulation(Baseline)
- Percentage of Participants Who Received Water-based and Ethanol-based Formulation(Baseline)
- Percentage of Participants Who Received 200 mg Loading Dose(Day 1)
- Percentage of Participants Who Received 100 mg Dose on Day 2(Day 2)
- Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses(Baseline up to Day 28 post-treatment)
- Number of Participants With Other Dosing Patterns(Baseline up to Day 28 post-treatment)
- Duration of Anidulafungin Therapy(Baseline)
- Number of Serious Adverse Events (SAEs)(Baseline up to Day 28 post-treatment)
- Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs)(Baseline up to Day 28 post-treatment)
- Number of Participants With Different Types of Drug-related Serious Adverse Events(Baseline up to Day 28 post-treatment)
研究者
研究点 (1)
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