CTRI/2018/05/013668招募中3 期
Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SCY 078 in Patients with Candidiasis, Including Candidemia, Caused by Candida auris.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- SCYNEXIS Inc
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
入选标准
- •1.Subject is a male or female adult ââ?°Â¥18 years of age on the day the study informed consent form (ICF) is signed.
- •2.Subject has a documented candidiasis, including candidemia,caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances.
- •A documented candidiasis, including candidemia, caused by Candida auris is defined as the
- •recovery of Candida auris by culture of a sample obtained within the last 7 days.
- •3.Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube.
- •4.Subject is not pregnant and is highly unlikely to become pregnant or to impregnate a partner since he/she meets at least one of the following criteria:
- •a.Subject is a female subject who is not of reproductive potential and is eligible without
- •requiring the use of contraception. A female subject who is not of reproductive potential
- •is defined as one who: (1) has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy; or (3) has undergone bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (i.e., anorexia nervosa).
- •b.Subject is a male subject who is not of reproductive potential and is eligible without
- •requiring the use of contraception. A male subject who is not of reproductive potential is
- •defined as one whom has undergone a successful vasectomy. A successful vasectomy is defined as (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
- •c.Subject is a male or female subject who is of reproductive potential and agrees to remain
- •abstinent or use (or have his/her partner use) 2 acceptable methods of contraception starting from the time of consent through 28 days after the completion of study therapy.
- •Acceptable methods of birth control are intrauterine device, condom, hormonal contraceptives and vasectomy.
- •It is not yet known if the use of SCY-078 reduces the efficacy of hormonal contraception (including but not limited to oral, injectable, or implantable methods). Therefore,
- •hormonal contraception should not be used without a second study acceptable method of
- •birth control.
- •Note:Women of childbearing potential must have a negative serum pregnancy test (Ã?²-human
- •chorionic gonadotropin [Ã?²-hCG]) prior to enrollment (performed by the siteââ?¬•s local
- •laboratory).
- •5.Subject and/or legal representative is/are able to understand and sign a written ICF, which must be obtained prior to treatment and any study-related procedures.
- •6.Subject and/or legal representative is able to understand and sign a consent or authorization form, which shall permit the use, disclosure and transfer of the subjectââ?¬•s personal health information (e.g., in the US, a Health Information Portability and Acc
排除标准
- •1.Subject has a fungal disease with central nervous system involvement.
- •2.Subject has a fungal disease of the bone and/or joint that is expected to require >90 days of study drug treatment.
- •3.Subject has an inappropriately controlled fungal infection source (e.g. persistent catheters, devices, identified abscess) that is likely the source of the fungal infection.
- •4.Subject is hemodynamically unstable and/or requiring vasopressor medication for blood
- •pressure support.
- •5.Subject has abnormal liver test parameters: AST or ALT >10 x ULN and/or total bilirubin >5
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