Pharmacokinetic Study of Rezafungin in Patients with Suspected Intra-Abdominal Candidiasis: Peritoneal Diffusion and Candicidal Activity
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Peritoneal diffusion rate of Rezafungin. Ratio of Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid to Cmax, Cmin and Area Under the Rezafungin Curve in blood.
研究概览
简要总结
To analyse the following PK parameters: Cmax, Cmin and area under the curve of rezafungin in blood and peritoneal fluid in patients with suspected intra-abdominal candidiasis. To evaluate the Candicidal activity of peritoneal fluid against two reference strains of Candida albicans and Candida glabrata, using kill curves.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed or unconfirmed suspicion of candidal peritonitis or intra-abdominal Candida spp. infection who, after receiving information about the study design, the purpose of the study, the potential risks involved and that they may refuse to participate at any time, give written consent to participate in the study.
- •Be over 18 years of age.
- •Understand the purpose of the study and be available to perform the visits and procedures established in the protocol.
- •In women: negative urine pregnancy test performed within 7 days prior to the start of study treatment in women of childbearing age and if < 2 years have passed since menopause.
- •Patients with signs of peritonitis or intra-abdominal infection who show refractoriness after at least 48 hours of empirical or specific antibiotherapy and in whom candidiasis infection is suspected.
- •Patients with an abdominal or peritoneal drain with a permeable debit that allows peritoneal samples to be obtained through it.
排除标准
- •Patients in whom there is a contraindication for use in accordance with the terms of the technical data sheet or known hypersensitivity to rezafungin or whose participation is not advisable in the opinion of the investigator.
- •Patients who do not present suspicion of intra-abdominal candidiasis or who are receiving antifungal treatment for another reason.
- •Patients receiving another antifungal drug during rezafungin administration.
结局指标
主要结局
Peritoneal diffusion rate of Rezafungin. Ratio of Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid to Cmax, Cmin and Area Under the Rezafungin Curve in blood.
Peritoneal diffusion rate of Rezafungin. Ratio of Cmax, Cmin and Area Under the Rezafungin Curve in peritoneal fluid to Cmax, Cmin and Area Under the Rezafungin Curve in blood.
Analysis of peritoneal fluid death curves in the samples per patient obtained according to the previous point.
Analysis of peritoneal fluid death curves in the samples per patient obtained according to the previous point.
次要结局
- Duration of treatment.
- Overall mortality
- Attributable mortality.
- Clinical and microbiological cure.
研究者
Itziar de Pablo López de Abechuco
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y Cajal