TCTR20230316005尚未招募3 期
Oral Voriconazole-based Empirical Treatment Protocol for Peritoneal Dialysis-related Fungal Peritonitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 115
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- All
入选标准
- •1. Patients undergoing maintenance peritoneal dialysis
- •2. Patients must have active peritoneal dialysis-related peritonitis according to the ISPD criteria
- •3. Diagnosis of fungal peritonitis confirmed by one of the following:
- •3.1 Identification of fungi by microscopic study of PD effluent or any PD-related specimens including particles in the removed PD catheter
- •3.2 A positive culture for fungi in the PD effluent or PD-related specimens
排除标准
- •1. The morphology of the causative fungus is non-septated hyphae suspected to be Zygomycetes.
- •2. Patients with severe sepsis or septic shock defined by fulfilling criteria for systemic inflammatory response syndrome (SIRS) together with organ failure or shock
- •3. Patients suspected to have secondary peritonitis by the presence of any of the followings: localized abdominal tenderness, fecal or bile contents in the PD effluent, multiple bacterial and/or fungal organisms identified in the PD effluent, or radiologic evidence of intrabdominal diseases such as intestinal obstruction or perforation
- •4. Patients with co-infection by other non-fungal pathogens identified in the same clinical specimens that isolate the fungus
- •5. Patients with decompensated liver disease including acute liver failure and decompensated cirrhosis (Child B, C)
- •6. Patients with QTc >0.500 seconds or QTc >0.45 seconds with evidence of underlying cardiomyopathy
- •7. Pregnant or lactating women
- •8. Patients with terminal illnesses including end-stage cardiopulmonary disease or advance stage cancer who are expected to live less than 1 year
- •9. Patients with a history of hypersensitivity (any degree) to azole drugs
研究者
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