PHASE II TRIAL OF AMPHOTERICIN B FOR FLUCONAZOLE RESISTANT ORAL CANDIDIASIS

这是一项评估疗效的开放标签多中心临床试验

This is an open label multicenter clinical trial assessing the efficacy and toxicity of amphotericin B oral suspension in the treatment of fluconazole-resistant oral candidiasis. Subjects will be treated with 5ml of amphotericin B oral suspension four times daily for 14 or 28 days. The subjects that respond after 14 days will be transferred to maintenance phase, where they will be subjects that do not fully respond after 14 days will continue induction therapy 14 more days. Full responders at day 28 will be transferred to the maintenance phase of the study, while failures from days 14 and 28 and non-full responders from day 28 and non-full responders from day 28 will be discontinued from study. The subject would then be treated at his/her physician's discretion. Responders from day 14 and 28 will be pooled into one group for final analysis, and will be used to determine the efficacy of amphotericin oral solution.