EUCTR2015-005599-51-BE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
- 220
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
- •Subjects must meet ALL of the following inclusion criteria to be enrolled:
- •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. Subjects receiving only medications and measures for comfort and not cure should not be enrolled.
- •4. Female subjects of child-bearing potential <2 years postmenopausal must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus 1 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 be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide) and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
- •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 1 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 114
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •Subjects must NOT meet any of the following exclusion criteria to be enrolled:
- •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.
- •a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated at Screening in qualifying cultures 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 PI 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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