EUCTR2011-003938-14-GB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 (Phase 3; Protocol No. MK-5592-069) - Posaconazole versus Voraconazole for Invasive Aspergillosis Treatment
Merck Sharp & Dohme Ltd0 个研究点目标入组 585 人开始时间: 2013年2月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 585
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
- •Each patient:
- •1. Must be willing and able to provide written informed consent for the trial. The legal representative (e.g. parent or guardian) for a patient under the age of legal consent or who otherwise is unable to provide independent consent may provide written informed consent for the patient. Each patient 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. Must be =18 years of age weighing >40 kg [88 lb] and =150 kg [330 lb] at the time of randomisation. Patients may be of either sex and of any race/ethnicity.
- •3. Must meet the criteria for proven, probable, or possible IA as per 2008 EORTC/MSG disease definitions at the time of randomisation.
- •4. With possible IA at time of randomisation 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-randomisation. 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. 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. Must have acute IA defined as duration of clinical syndrome of <30 days.
- •7. Must be willing to adhere to dosing, study visit schedule, and mandatory procedures as outlined in the protocol.
- •8. Must have the ability to transition to oral study therapy during the course of the study.
- •9. Female participants of child-bearing potential must be using a medically
- •accepted method of birth control before beginning study-drug treatment and
- •agree to continue its use for 30 days after stopping the medication, or have been surgically sterilized (e.g., hysterectomy or tubal ligation.
- •10. To participate in the pharmacogenetic analysis, the participant must be willing to give written informed consent for the pharmacogenetic testing and able to adhere to dose and visit schedules.
- •11.Participant is not taking prohibited antifungal prophylaxis or treatment as defined by the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
- •Patients will be excluded if they:
- •1. Have chronic (>1 month duration) IA, relapsed/recurrent IA, or refractory IA which has not responded to prior antifungal therapy.
- •2. Have sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis (ABPA).
- •3. Have 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. Have received any systemic (oral, intravenous, or inhaled) antifungal therapy for this infection episode for 4 or more consecutive days immediately prior to randomisation.
- •5.The patient 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
- •6. Have received POS or VOR as empirical (experimental)treatment for this infection for 4 days (96 hours) or more within the 15 days immediately prior to randomisation.
- •7. Have received any treatment specifically listed in Table 2 (page 49 of the protocol) which is more recent than the indicated washout period prior to randomisation.
- •8. Have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study, i.e., any condition requiring the use of prohibited drugs or unstable medical conditions other than the hematological disorder such as cardiac or neurologic disorder or impairment expected to be unstable or progressive during the course of this study (e.g., seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, or unstable congestive heart failure, unstable arrhythmias, atrial fibrillation with ventricular rate <60/min, or history of
- •torsades de pointes, symptomatic ventricular or sustained arrhythmias, unstable electrolyte abnormalities [e.g., = Grade 2 hypokalemia or hypomagnesemia]).
- •9. Have known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study medication used.
- •10. The female patient is pregnant, intends to become pregnant, or is nursing at the time of randomisation.
- •11. Have any known history of Torsade de Pointes, unstable cardiac arrhythmia or proarrhythmic conditions, or a history of recent myocardial infarction within 90 days of study entry.
- •12. Have QTc (either Fridericia or Bazett’s correction) interval = 500 msec on electrocardiogram performed at screening or baseline.
- •13. Have significant liver dysfunction (defined as total bilirubin > 1.5 times upper limit of normal AND AST or ALT > 3 times upper limit of normal with normal alkaline phosphatase [ALP] on screening labs) at the time of randomisation.
- •14. Have hepatic cirrhosis or a Child-Pugh score of C (severe hepatic impairment) at the time of randomisation. See Appendix 4 for Child-Pugh Classification.
- •15. The patient has severe renal insufficiency (estimated creatinine clearance <20 mL/min) or on haemodialysis at the time of randomisation or is likely to require dialysis during the study.
- •16. Have a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucosegalactose malabsorption.
- •17. Have acute symptomatic pancreatitis within 6 months of study entry or has a diagnosis of c
研究者
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