NCT00811642已完成3 期
A Multicenter, Open Label Study to Evaluate Safety and Efficacy of Posaconazole Oral Suspension in Treatment of Invasive Fungal Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
研究概览
简要总结
The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18-70 years male or female
- •Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.
- •Sign informed consent form
排除标准
- •Female participants who are pregnant or are nursing.
- •Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
- •Participants with progressive nervous system diseases( excluding those IFI caused)
- •Participants who take the following drugs known with interference with azole antifungal preparations
- •terfenadine, cisapride, and ebastine within 24 hours before entry
- •astemizole at entry or within 10 days before entry
- •cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
- •The drugs listed above are prohibited during the investigation
- •Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
- •Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
- •Expected to take during investigation or is taking systemic antifungal treatment
- •Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are >2×ULN.
- •Participants expected to survive no more than 72hrs
- •Participants receiving artificial aeration and will not withdraw within 24hrs
- •Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry.
- •Prior enrollment in this study.
- •History of alcohol and/or drug abuse.
- •Participants cannot be compliant in investigator's opinion.
研究组 & 干预措施
Posaconazole
Experimental
Posaconazole 400 mg twice a day (BID) oral suspension for 12 weeks
干预措施: Posaconazole (Drug)
结局指标
主要结局
Number of Participants Who Had Clinical Response at 12 Weeks With Posaconazole Treatment
时间窗: Treatment week 12
EVALUATION OF PARTICIPANTS' CLINICAL RESPONSE BASED ON CRITERIA: Complete Response: resolution of Invasive Fungal Infection (IFI) attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment. Partial Response: clinically significant improvement in IFI attributable symptoms, signs and laboratory or etiological abnormalities, if present at enrollment, of which, one still had not achieved complete recession. Stable disease: no progress in IFI attributable symptoms, if present at enrollment. Failure: deterioration in IFI attributable clinical symptoms.
次要结局
- Number of Participants Who Had Clinical Response at 4 Weeks With Posaconazole Treatment(Treatment week 4)
- Number of Participants Who Had Clinical Response at 8 Weeks With Posaconazole Treatment(Treatment week 8)
- Number of Participants With Pathogenic Fungal Eradication at 4 Weeks With Posaconazole Treatment(Treatment week 4)
- Number of Participants With Pathogenic Fungal Eradication at 8 Weeks With Posaconazole Treatment(Treatment week 8)
- Number of Participants With Pathogenic Fungal Eradication at 12 Weeks With Posaconazole Treatment(Treatment week 12)
- Number of Participant Survivors at Week 14 of Post-Posaconazole Treatment Follow-up(Follow-up week 14)
研究者
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