150 603:TRIAL OF VORICONAZOLE VS AMBISOME FOR ANTIFUNGAL THERAPY IN H

这项研究的目标是招募786名符合纳入改良意向治疗分析的受试者。这项研究比较了伏立康唑和氨比妥在治疗免疫功能低下的持续发热和中性粒细胞减少症患者的真菌感染方面的有效性、安全性和耐受性、存活率、突破性深度侵袭性真菌感染的发生率和退热时间。参加这项研究的大多数受试者将接受经验性抗真菌药物治疗，直到中性粒细胞减少症恢复(通常为两周)，并在最后一次经验性治疗后7天进行后续临床评估。被诊断为深度侵袭性真菌感染的受试者可以接受治疗，直到感染消失，最长可达12周。符合所有纳入/排除标准的患者将被随机分配，接受静脉注射伏立康唑至少3天，然后口服伏立康唑，直到中性粒细胞减少症恢复，或静脉注射AmBisome，直到中性粒细胞减少症恢复。患者将在研究治疗开始时住院治疗，并将一直住到中性粒细胞减少症恢复。评估将每周进行，直到中性粒细胞减少症恢复。没有基线或突破性深度侵袭性真菌感染的患者将在研究用药期间、治疗结束时和治疗结束后四周进行额外的评估。评估将包括住院、伴随疾病、眼科安全评估、不良事件、同时用药、生命体征和实验室分析。

This study aims to recruit 786 subjects who are eligible for inclusion in the modified intent-to-treat analysis. The study compares the efficacy, the safety and tolerance, the survival, the incidence of breakthrough deeply invasive fungal infections and the time to defervescence of voriconazole versus Ambisome, in the empirical treatment of fungal infections in immunocompromised patients with persistent fever and neutropenia. The majority of the subjects enrolled in this study will be treated with empirical antifungal medication until recovery from neutropenia (typically two weeks), with a follow-up clinical assessment seven days after the last dose of empirical therapy. Subjects who are diagnosed with a deeply invasive fungal infection can be treated until resolution of the infection up to a maximum of twelve weeks. Patients meeting all inclusion/exclusion criteria will be randomly assigned to receive treatment with either IV voriconazole for at least 3 days, followed by oral voriconazole, until recovery from neutropenia or IV AmBisome until recovery from neutropenia. Patients will be hospitalized at the beginning of study treatment and will remain until recovery from neutropenia. Assessments will be performed weekly until recovery from neutropenia. Patients without baseline or breakthrough deeply invasive fungal infections will have additional assessments performed every four weeks while on study medication, at the end of treatment, and at four weeks after the end of treatment. Evaluations will include hospitalizations, concomitant illnesses, ophthalmological safety assessment, adverse events, concurrent medications, vital signs, and laboratory analysis.