EUCTR2011-003938-14-ES进行中（未招募）1 期
A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Each subject must be willing and able to provide written informed consent for the trial. The legal representative (e.g. parent or guardian) for a subject under the age of legal consent or who otherwise is unable to provide independent consent may provide written informed consent for the subject. Each subject of the age of assent must be willing and able to provide assent in addition to consent from the legal representative to participate in the trial.
- •2. Each subject must be > or = to 13 years of age weighing >40 kg [88 lb] and < or = to 150 kg [330 lb] at the time of randomization. Each subject between 13 and 14 years of age must weigh > or = to 50 kg [110 lb]. Subjects may be of either sex and of any race/ethnicity.
- •3. Each subject must meet the criteria for proven, probable, or possible invasive aspergillosisIA as per 2008 EORTC/MSG disease definitions at the time of randomization. Proven IA will include those subjects with the demonstration of fungal elements (by cytology, microscopy, or culture) in diseased tissue (sterile sampling). Probable IA includes subjects with at least 1 host factor, clinical criteria, as well as mycological criteria including both direct and indirect (i.e., detection of serum, or BAL fluid Aspergillus galactomannan antigen by sandwich EIA) methods. If using the galactomannan test for diagnosis, a positive test results is defined as a cut-off index of > or = to 1.0 for both serum and BAL. Two positive test results will qualify the subject for meeting the criteria as probable IA. Possible IA includes subjects with at least 1 host factor and clinical criteria but without mycological criteria. See Appendix 3 for tables of diagnostic criteria.
- •4. Each subject with possible invasive aspergillosisIA at time of randomization must be willing or be in process of an ongoing diagnostic work up which is anticipated to result in a mycological diagnosis of proven or probable IA within 7 days post-randomization. In the event this does not result in mycological diagnosis of proven or probable IA, the patient must be willing to continue on study therapy and remain in the study.
- •5. Each subject must have a central catheterline (e.g., central venous catheter, peripherally-inserted central catheter, etc.) in place or planned to be in place prior to beginning IV study therapy.
- •6. Each subject must have acute invasive aspergillosisIA defined as duration of clinical syndrome of <30 days.
- •7. Each subject must be willing to adhere to dosing, study visit schedule, and mandatory procedures as outlined in the protocol.
- •8. The subject must have the ability to transition to oral study therapy during the course of the study or be willing to receive the entire 12-week study treatment course intravenously.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 200
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1.The subject has chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory IA which has not responded to prior antifungal therapy.
- •2.The subject has sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA).
- •3.The subject has a known mixed invasive mold fungal infection including Zygomycetes, and/or a known invasive Aspergillus fungal infection in which either study drug may not be considered active.
- •4.The subject has received any systemic (oral, intravenous, or inhaled) antifungal therapy for this infection episode for 4 or more consecutive days immediately prior to randomization.
- •5.The subject is taking mold-active antifungal prophylaxis and the IA infection is considered to be a breakthrough. A breakthrough IA infection is one that develops after the initiation of 13 days or more of preventative systemic antifungal therapy.
- •6.The subject has received POS or VOR as empirical treatment for this infection for 4 days (96 hours) or more within the 15 days immediately prior to randomization.
研究者
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