NCT01122368已完成2 期
An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 252
- 主要终点
- The incidence of Invasive Fungal Infection
研究概览
简要总结
Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.
详细描述
Subjects will be assessed at the following visits:
- Baseline (after surgery, prior to randomization)
- End of Treatment (EOT) visit (EOT is defined as: requires alternative antifungal, sufficient improvement of surgical condition, confirmed fungal infection or death)
- End of Study visit (28 days after the EOT visit)
- Long-term Follow up visit (90 days after the EOT visit)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Intra-abdominal infection requiring surgery and Intensive Care Unit stay
- •If Community Acquired Intra-Abdominal Infection, at least 72 hours (but not more than 120 hours) of Intensive Care Unit stay, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
- •If Nosocomial Intra-Abdominal Infection, duration of Intensive Care Unit stay ≤ 48 hours, counted from the end of surgery, and a further expected duration of Intensive Care Unit stay of ≥ 48 hours
- •Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain highly effective birth control during the study
排除标准
- •Acute pancreatitis
- •Neutropenia (ANC <1,000/mm3) at the time of randomization
- •Infected intra-peritoneal dialysis
- •Patients undergoing solid organ transplantation
- •Documented invasive candidiasis at the time of randomization
- •Expected survival < 48 hours
- •Any systemically active anti-fungal within 14 days prior to administration of the study drug
- •Allergy, hypersensitivity, or any serious reaction to an echinocandin anti-fungal or any of the study drug excipients
- •Currently receiving and/or has taken an investigational drug within 28 days prior to randomization
- •Pregnant woman or breast-feeding mother
- •'Do Not Resuscitate' order
研究组 & 干预措施
1 Micafungin
Experimental
IV
干预措施: micafungin (Drug)
2 Placebo
Placebo Comparator
IV
干预措施: placebo (Drug)
结局指标
主要结局
The incidence of Invasive Fungal Infection
时间窗: During treatment
Time from baseline to the first confirmation of Invasive Fungal Infection
时间窗: Baseline to End of Treatment visit
次要结局
- All-cause mortality(At the End of Study and Long-Term Follow Up visit)
- Organ failure-free days(From Day 1 until 28 days after end of study drug treatment)
- Assessment of the safety of micafungin when used as a pre-emptive treatment(At the End of Study visit)
- Health-related quality of life(At the End of Study visit)
- The level of organ dysfunction(At the EOT visit)
- Fungal-free survival(From Day 1 until 28 days after end of study drug treatment)
- Intensive Care Unit (ICU)-free days(From Day 1 until 28 days after end of study drug treatment)
- The incidence during the treatment period and the time to confirmation of the composite endpoint (defined as confirmation of Invasive Fungal Infection and/or administration of alternative anti-fungal therapy)(At the EOT visit)
- The emergence or persistence of fungal colonization(At the EOT visit)
- To assess the requirement for additional abdominal surgery/intervention.(At the End of Study visit)
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