A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 12
- 主要终点
- Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.
研究概览
简要总结
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.
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
- •Non-pregnant >18 yrs of age
- •Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
- •Subjects meeting the clinical prediction rule
排除标准
- •Subjects with an allergy/intolerance to caspofungin or echinocandin analog
- •absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
- •acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
- •moderate or severe hepatic insufficiency
- •subjects who are pregnant or lactating
- •unlikely to survive < 24 hours
- •subjects who have received systemic antifungal therapy within 10 days prior to study entry
- •Documented active proven or probable invasive fungal infection upon enrollment
- •previously enrolled in this study
- •Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
研究组 & 干预措施
1 prophylaxis
Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy
干预措施: Caspofungin (Drug)
2 placebo
Normal Saline 100 cc IV daily
干预措施: Normal Saline (Drug)
结局指标
主要结局
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.
时间窗: Within 7 days after end of therapy
Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.
次要结局
- All Cause Mortality(Within 7 days of end of therapy)
- Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.(Within 7 days of end of therapy)
- Initiation of Other Antifungals(Within 7 days after end of therapy)
- Time to Development of Proven or Probable Invasive Candidiasis(Within 7 days after end of therapy)
- Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.(Within 7 days after end of therapy)
- Time to Beta Glucan Negativity in Pre-emptive Phase.(Within 14 days after end of therapy)
- Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.(Within 14 days after end of therapy)
- Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.(Hospital discharge)
- Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event(Up to 14 days after end of therapy)
- Subjects With 1 or More Serious Drug-related Adverse Event(s)(Up to 14 days after end of therapy)