NCT00388167已完成不适用
PROCAS: Study Observational Prospective and Multicenter to Determine the Clinic Effectiveness and the Safety of Caspofungin Acetate (CANCIDAS®) in the Treatment of Invader Fungal Infection
PETHEMA Foundation27 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2004年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 27
研究概览
简要总结
We wanted to determine the efficacy and the safety of caspofungin acetate (CANCIDAS®) in the treatment of invader fungal infection (IFI) specifically, Invasive Candidiasis (CI) in adults patients without neutropenia and Invasive Aspergillosis (AI) in adults patients who are refractory to or intolerant of other therapies (i.e., amphotericin B, lipid formulations of amphotericin B, and/or itraconazole).
详细描述
Study post-marketing (observational). It is multicenter and prospective. No masking is used, without control group neither is randomized
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Female and male with 18 years old at least.
- •Diagnosis of AI or CI. It will be based in Clinical History, signs and symptoms that the patient takes, discovery of studies of radiology and results of cultivation and/or studies of anatomopathology positives for Candida spp. or Aspergillus spp.
- •Patients with AI, must be refractory to or intolerant of other therapies antifungal used in the hospital.
- •Patients with CI, must be or not refractory to or intolerant of other therapies antifungal used in the hospital.
排除标准
- •Patients with diagnosis uncertain based in one or more of next criterions: Cultivation positive for Candida in an only localization (urine, spittle, end/current of catheter; osteomyelitis or endocarditis by Candida without treatment appropriated surgical; infection by Candida of prosthetic material without retired of the same; positive blood cultive for Candida in appearance of vascular prosthesis; allergic lung Aspergillosis; and aspergilloma or aspergillosis eye without treatment appropriated surgical).
- •Allergic / hypersensitivity to caspofungin.
- •Insufficiency several liver (rate of Chile-Pugh >9).
- •Prediction of survival <5 days.
- •Pregnant or breast feeding.
- •Previous Participation of patient in this study.
- •Presence of other disease or any condition that it can mix up the interpretation of results or create risks.
- •Previous Participation of patient in other clinical study that it involve the administration of a drug in investigation in the 14 days previous to your inclusion in the study or during the administration of caspofungin. We can include patients took with antineoplastic drugs in research whenever at lefts a Investigator Coordinator authorizes it before
研究组 & 干预措施
1
Caspofungin
干预措施: Caspofungin (Drug)
研究者
研究点 (27)
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