EUCTR2011-003938-14-LT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)
适应症
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 =18 years of age weighing >40 kg [88 lb] and =
- •150 kg [330 lb] at the time of randomization. Subjects may be of either
- •sex and of any race/ethnicity.
- •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. If using
- •the galactomannan test for diagnosis, a positive test results is defined as
- •two consecutive serum values of =0.5 or a single serum value =1.0.
- •Similarly, a single value of =1.0 in a BAL sample would qualify the
- •subject for meeting the criteria as 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. 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 within 7 days
- •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
- •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 3-month follow-up.
- •8. The subject must have the ability to transition to oral study therapy
- •during the course of the study.
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 has developed the current episode of IA infection
- •(possible, probable, or proven infection) during the receipt of more than
- •13 days of antifungal prophylaxis that is considered to be a mold-active
- •antifungal agent (including itraconazole, posaconazole, voriconazole,
- •isavuconazole, inhaled or systemic amphotericin or lipid-associated
- •amphotericin, and echinocandin agents).
- •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
相似试验
进行中（未招募）
1 期
MK-5592 Protocol 069 (POS vs VOR for the treatment of a fungal infection (Invasive Aspergillosis) in Adults and AdolescentsEUCTR2011-003938-14-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.600
进行中（未招募）
1 期
MK-5592 Protocol 069 (POS vs VOR for the treatment of a fungal infection (Invasive Aspergillosis) in AdultsEUCTR2011-003938-14-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.600
进行中（未招募）
1 期
MK-5592 Protocol 069 (POS vs VOR for the treatment of a fungal infection (Invasive Aspergillosis) in Adults and AdolescentsInvasive aspergillosisMedDRA version: 18.0 Level: LLT Classification code 10003488 Term: Aspergillosis System Organ Class: 100000004862EUCTR2011-003938-14-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.600
进行中（未招募）
1 期
MK-5592 Protocol 069 (POS vs VOR for the treatment of a fungal infection (Invasive Aspergillosis) in Adults.Invasive aspergillosisMedDRA version: 20.0Level: LLTClassification code 10003488Term: AspergillosisSystem Organ Class: 100000004862EUCTR2011-003938-14-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.585
进行中（未招募）
1 期
MK-5592 Protocol 069 (POS versus VOR for the treatment of a fungal infection (Invasive Aspergillosis) in AdultsInvasive aspergillosisMedDRA version: 17.0Level: LLTClassification code 10003488Term: AspergillosisSystem Organ Class: 100000004862EUCTR2011-003938-14-GBMerck Sharp & Dohme Ltd585