An Efficacy of The Protocol-based Empirical Treatment With 4-week Oral Voriconazole for Peritoneal Dialysis-related Fungal Peritonitis

Faculty of Medicine, Chulalongkorn University0 个研究点目标入组 100 人开始时间: 2024年4月2日最近更新: 2024年8月19日

适应症

试验速览

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•1. Patients >18 years old undergoing PD
•2. Patients must have active PD-related peritonitis according to ISPD criteria
•3. Diagnosis of fungal peritonitis confirmed by any 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

•1. 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 following: 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
•- Patients with decompensated liver disease including acute liver failure and decompensated cirrhosis (Child B, C)
•5. Patients with QTc >0.500 seconds or QTc >0.45 seconds with evidence of underlying cardiomyopathy
•6. Pregnant or lactating women
•7. Patients with terminal illnesses including end-stage cardiopulmonary disease or advance stage cancer who are expected to live less than 1 year
•8. Patients with a history of hypersensitivity (any degree) to azole drugs

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