EUCTR2011-003938-14-PL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
- 性别
- All
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 =13 years of age weighing >40 kg [88 lb] and =150 kg [330 lb] at the time of randomization. Each subject between 13 and 14 years of age must weigh = 50 kg [110lb]. Subjects may be of either sex and of any race/ethnicity. For those sites that do not have the ability to enroll adolescents, subjects must be greater than =18 years of age.
- •3.Each subject must meet the criteria for proven, probable, or possible IA 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. Two consecutive serum galactomannan EIA values =0.5 or a single value of =1.0 may be used as the sole microbiological criterion for probable IA. A single galactomannan EIA value of =1.0 in a BAL sample may be used to meet the microbiological criteria for probable IA. For subjects receiving piperacillin/tazobactam within 72 hours of serum galactomannan sampling, serum galactomannan criteria for probable IA will not meet the criteria for probable IA. Possible IA includes subjects with at least 1 host factor and clinical criteria but without mycological criteria. A modification to the 2008 EORTC/MSG criteria regarding risk factors has been made to allow for the inclusion of subjects with any duration of neutropenia as an acceptable inclusion host factor. See Appendix 3 for tables of diagnostic criteria.
- •4.Each subject with possible IA 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 post-randomization.
- •5.Each subject must have a central line (e.g. central venous catheter, peripherally-inserted central catheter, etc.) in place or planned to be in place prior to beginning IV study therapy. Subjects without central catheter access must be clinically stable and able to receiving oral
- •study therapy.
- •6.Each subject must have acute IA 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. The subject must be willing to continue on study therapy for up to 12 weeks and remain in the study through the 1 month follow-up.
- •8.The subject must have the ability to transition to oral study therapy during the course of the study.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1.The subject has chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory invasive aspergillosis which has not responded to prior antifungal therapy.
- •2.The subject has chronic pulmonary aspergillosis, pulmonary 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 (=96 hours) immediately prior to randomization.
- •5.The subject has developed the current episode of IA infection (possible, probable, or proven infection ) during the receipt of more than 13 days of an azole or polyene antifungal agent given for prophylaxis that is considered to be a mold-active, antifungal agent(including itraconazole, posaconazole, voriconazole, isavuconazole, inhaled or systemic amphotericin or lipid-associated amphotericin), Any duration of echinocandin antifungal use is allowed (prior to randomization).
- •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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