A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 527
- 试验地点
- 81
- 主要终点
- All-cause Mortality Through Day 42
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
详细描述
Acute invasive fungal infections caused by aspergillus, zygomycetes and other filamentous fungi remain life threatening diseases. Early treatment with highly effective anti-fungals reduces mortality. This study investigates the efficacy and safety of isavuconazole in the treatment of invasive fungal diseases, caused by Aspergillus or other filamentous fungi.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi
- •Female patients must be non-lactating and at no risk for pregnancy
排除标准
- •Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
- •Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
- •Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary aspergillosis
- •Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication
- •Patients previously enrolled in a Phase III study with isavuconazole
- •Patients with a body weight </= 40 kg
研究组 & 干预措施
Isavuconazole
Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
干预措施: Isavuconazole (Drug)
Voriconazole
Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
干预措施: Voriconazole (Drug)
结局指标
主要结局
All-cause Mortality Through Day 42
时间窗: Through Day 42
All-cause mortality is represented as the percentage of participants who died after first dose of study drug through Day 42 from any cause. Participants with unknown survival status through Day 42 were included as deaths in the calculation.
次要结局
- Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC)(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- All-cause Mortality Through Day 84(Through Day 84)
- Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Percentage of Participants With a Clinical Response Assessed by the DRC(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Percentage of Participants With a Mycological Response Assessed by the DRC(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Percentage of Participants With a Radiological Response Assessed by the DRC(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Percentage of Participants With a Clinical Response Assessed by the Investigator(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Percentage of Participants With a Mycological Response Assessed by the Investigator(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Percentage of Participants With a Radiological Response Assessed by the Investigator(Day 42, Day 84 and End of Treatment. The median duration of study drug administration was 45 days.)
- Number of Participants With Adverse Events, Reported by System Organ Class(From the first study drug administration until 28 days after the last dose of study drug. The median duration of study drug administration was 45 days.)