EUCTR2015-005599-51-RO进行中（未招募）1 期
A Phase 2, Multicenter, Randomized, Double-blind Study of the Safety, Tolerability, and Efficacy of Intravenous CD101 vs Intravenous Caspofungin Followed by Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis
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
- 207
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Subjects must meet ALL of the following inclusion criteria:
- •1. Males or females >=18 years.
- •2. Established mycological diagnosis of candidemia and/or IC from a sample taken =<96 hours before randomization defined as:
- •a. >=1 blood culture positive for yeast or Candida
- •b. Positive test for Candida from a Sponsor-approved rapid IVD
- •c. Positive Gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site
- •3. Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
- •Patients receiving only medications and measures for comfort and not cure should not be enrolled.
- •4. Female subjects of child-bearing potential <2 years post-menopausal must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence while participating in this study. Male subjects must agree to and comply with using one barrier method of birth control (e.g., male condom with spermicide) or sexual abstinence.
- •5. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on their behalf.
- •6. Presence of one or more systemic signs attributable to candidemia and/or IC (e.g., fever, hypothermia, hypotension, tachycardia, tachypnea).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •Subjects must NOT meet any of the following exclusion criteria:
- •1. Any of the following forms of IC:
- •a. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
- •b. Osteomyelitis
- •c. Endocarditis or myocarditis
- •d. Meningitis, endophthalmitis, or any central nervous system infection.
- •2. Neutropenia (absolute neutrophil count =<500/mcL) at Screening or anticipated neutropenia during the study.
- •3. Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal.
- •4. Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9).
- •5. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for >48 hours (for example, >2 doses of a once daily antifungal agent or >4 doses of a twice daily
- •antifungal agent) in the last 96 hours before randomization.
- •Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible.
- •6. Pregnant females.
- •7. Lactating females who are nursing.
- •8. Known hypersensitivity to CD101 IV, caspofungin, any echinocandin, or to any of their excipients
- •9. Previous participation in this or any previous CD101 study.
- •10. Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of Screening.
- •11. The Principal Investigator considers that the subject should not participate in the study
- •12. Presence of an indwelling vascular catheter or device that cannot be removed and is likely to be the
- •source of candidemia.
研究者
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