Empirical Voriconazole vs. Amphotericin B plus Flucytosine in Peritoneal Dialysis Patients with Fungal Peritonitis: A Randomized Controlled Trial (VAF Study)

Ratchadapiseksompotch Fund0 个研究点目标入组 80 人开始时间: 2021年3月16日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Written informed consent obtained
•2.Patients >18 years old undergoing PD
•3.Diagnosis of fungal peritonitis confirmed by any of the following
•a.Identification of fungi by microscopic study of PD effluent or any PD-related specimens including particles in the removed PD catheter
•b.Positive culture for fungi in the PD effluent or PD-related specimens

•1.The morphology of 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 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 who have received any forms of anti-fungal drugs more than 3 days prior to enrolment except for nystatin or fluconazole at a prophylaxis dose
•5.Patients with co-infection by other non-fungal pathogens identified in the same clinical specimens that isolate the fungus
•6.Patients with decompensated liver disease including acute liver failure and decompensated cirrhosis
•7.Patients with QTc prolongation (>0.45 second)
•8.Pregnant or lactating women
•9.Patients with terminal illness including end-stage cardiopulmonary disease or advance stage cancer who are expected to live less than 1 year
•10.Patients with history of hypersensitivity (any degree) to amphotericin B or any drugs in the azole group

发起方

Ratchadapiseksompotch Fund