A Phase II Study on Treatment of Refractory Fungal Infections With Posaconazole. The "TIP" Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of posaconazole in the early treatment of fungal infections in participants who are refractory to, intolerant to, or medically precluded from first-line monotherapy or first-line combination antifungal therapy.
详细描述
In the past two decades, invasive fungal infections (IFI) have become increasingly common among immunocompromised people, including solid-organ or hematopoietic stem-cell transplant recipients, those with HIV infection, those with hematological malignancies, and individuals on immunosuppressive drug regimens. There is a high rate of morbidity and mortality associated with IFI. Over the past decade, there has been an increase in resistance to commonly used antifungal agents and an epidemiological shift to more drug-resistant strains. This has demonstrated the need for the development of a new generation of azoles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven or probable invasive fungal infection (IFI) including breakthrough infection while on antifungal treatment for at least 7 days.
- •Refractory or intolerant to prior antifungal therapy, or medically unable to receive standard antifungal therapy.
- •Age ≥13 years old.
- •Expected to survive >1 month.
- •Negative pregnancy test (serum or urine) at baseline for women of childbearing potential.
排除标准
- •Serum bilirubin >10 times upper limit of normal (ULN).
- •Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >10 times ULN.
- •Documented allergy to azoles.
- •Unable to take oral suspension medications or enteral feeding.
- •Pregnant or breastfeeding.
- •Participants who have received an investigational drug are allowed to be enrolled if the investigational drug was given 30 days prior to study registration, unless approved by the Sponsor.
- •Requires surgery.
研究组 & 干预措施
Posaconazole
Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
干预措施: Posaconazole (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) or Partial Response (PR) by 12 Weeks or End of Treatment
时间窗: Up to 6 months
Complete Response was defined as resolution of all attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline. Partial Response was defined as clinically meaningful improvement in attributable clinical signs and symptoms and radiologic and mycologic abnormalities, if present at baseline.
次要结局
- Overall Survival at 3 Months(3 months)
- Percentage of Participants With a CR or PR by 12 Weeks(Up to 12 Weeks)
- Percentage of Participants With CR or PR by 4 Weeks and by 26 Weeks(Up to 26 weeks)
- Percentage of Participants With Infection-free Survival After the Last Dose of Study Drug(Up to 6 months)
- Number of Participants With Response to Posaconazole in Combination Therapy(Up to 6 months)
- Number of Participants Experiencing Adverse Events (AEs)(Up to 12 months)
- Number of Participants With ≥50% Decrease in Lesion Size or Number(Up to 6 months)