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

本研究旨在招募786例有资格入选改良意向治疗分析的受试者。 该研究比较了伏立康唑与AmBisome经验性治疗持续发热和中性粒细胞减少的免疫功能低下患者真菌感染的疗效、安全性和耐受性、生存率、突破性深部侵袭性真菌感染的发生率和退热时间。 入组本研究的大多数受试者将接受经验性抗真菌药物治疗，直至从中性粒细胞减少症中恢复（通常为2周），并在经验性治疗末次给药后7天进行随访临床评估。 被诊断患有深度侵袭性真菌感染的受试者可以被治疗直到感染消退最多十二周。 符合所有入选/排除标准的患者将被随机分配接受IV伏立康唑治疗至少3天，随后口服伏立康唑，直至从中性粒细胞减少症中恢复，或IV AmBisome直至从中性粒细胞减少症中恢复。患者将在研究治疗开始时住院，并将继续住院直至从中性粒细胞减少症中恢复。 每周进行一次评估，直至中性粒细胞减少症恢复。 基线或突破性深部侵袭性真菌感染的患者将在研究药物治疗期间、治疗结束时和治疗结束后4周每4周进行一次额外评估。评价将包括住院、伴随疾病、眼科安全性评估、不良事件、合并用药、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 criterial 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.