EUCTR2018-002630-21-DE进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection versus Intravenous CaspofunginFollowed by Optional Oral Fluconazole Step-down in the Treatment of Subjects with Candidemia and/or Invasive Candidiasis (The ReSTORE Study)
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
- 218
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 the following inclusion criteria to qualify for the study:
- •1. Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative (i.e., acceptable to International Council on Harmonisation [ICH] and local law, as applicable) must provide informed consent on his/her behalf.
- •2. Males or females =18 years of age.
- •3. Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken =4 days (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 (or other method of direct microscopy) for yeast or positive culture
- •for Candida spp. from a specimen obtained from a normally sterile site.
- •4. Presence of one or more systemic signs attributable to candidemia or invasive candidiasis (e.g., fever, hypothermia, hypotension, tachycardia, tachypnea, local signs of inflammation) appearing from =12 hours prior to the qualifying positive culture through time of randomization.
- •5. 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.
- •6. Female subjects of childbearing potential (all female subjects between 18 years and <2 years post-menopausal unless surgically sterile) 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 (only possible if it corresponds to the subject's usual lifestyle) while participating in this study and at least 30 days from the last dose of study drug. 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 while participating in this study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
- •7. For candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Subjects must NOT meet any of the following exclusion criteria to qualify for the study:
- •1. Any of the following forms of invasive candidiasis at baseline:
- •a. Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
- •b. Osteomyelitis
- •c. Endocarditis or myocarditis
- •d. Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection
- •e. Chronic disseminated candidiasis
- •f. Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract
- •2. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for >48 hours (e.g., >2 doses of a once daily antifungal agent or >4 doses of a twice daily antifungal agent) and =4 days (96 hours) before randomization
- •a. Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible
- •3. Alanine aminotransferase or aspartate aminotransferase levels >10-fold the upper limit of normal (ULN).
- •4. Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score >9)
- •5. Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis
- •6. Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients, including but not limited to hereditary sugar disorders (e.g., fructose intolerance, sucrose-isomaltase insufficiency), anaphylaxis, or echinocandin-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis).
- •7. Meets National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher
- •8. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson’s Disease or Huntington’s Disease)
- •9. Planned or ongoing therapy at Screening with a known severe neurotoxic medication or with a known moderate neurotoxic medication in a patient with ataxia, tremor, motor neuropathy, or sensory neuropathy of CTCAE version 5.0 Grade 1 or higher
- •10. Previous participation in this or any previous rezafungin study
- •11. Current participation in another interventional treatment trial with an investigational agent.
- •12. 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.
- •13. Pregnant or lactating females.
- •14. The Principal Investigator (PI) is of the opinion the subject should not participate in the study.
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