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
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- To evaluate the efficacy of SCY-078 as determined by a Data Monitoring Committee (DMC) by assessing global success (composite assessment of clinical and mycological success) at End
研究概览
简要总结
Candida auris is an emerging fungus that presents a serious global health threat. Healthcare facilities in several countries have reported that C. auris has caused severe illness in hospitalized patients. Some strains of Candida auris are resistant to all three major classes of antifungal drugs.This type of multidrug resistance has not been seen before in other species of Candida. Also of concern, C. auris can persist on surfaces in healthcare environments and spread between patients in healthcare facilities, unlike most other Candida species. The CDC surveillance data conducted in developed countries have reported that approximately 7% of all Candida bloodstream isolates tested are resistant to fluconazole and some Candida strains are increasingly resistant to first-line and second-line antifungal treatment agents, including azoles and echinocandins. Centers specialized in the treatment of immune-compromised patients report increased frequency of non-albicans species of Candida with higher incidence of resistance.
India being burdened with multiple immunocompromised disease conditions, secondary infection with candida has higher prevalence rate and the incidence rate is increasing day by day. Many of the candida infectious conditions treated with existing antifungal drugs have developed resistance to these drugs. Lack of alternative treatment regimens have added up to high morbid and mortality rates in these conditions.
SCY-078 has been evaluated against >1600 Candida isolates, including all clinically relevant species, more than 400 C. glabrata isolates and >100 C. auris isolates.
The study will be conducted at approximately 10 sites globally, and is planned to enroll and treat approximately 30 subjects. Thus India will be one of the country to contribute for the global assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject is a male or female adult ≥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 (β-human chorionic gonadotropin [β-hCG]) prior to enrollment (performed by the site’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 subject’s personal health information (e.g., in the US, a Health Information Portability and Accountability Act Authorization form).
- •7.Subject and/or legal representative is able to understand and follow all study-related procedures including study drug administration.
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 x ULN.
结局指标
主要结局
To evaluate the efficacy of SCY-078 as determined by a Data Monitoring Committee (DMC) by assessing global success (composite assessment of clinical and mycological success) at End
时间窗: Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the DMC.
of Treatment (EoT).
时间窗: Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the DMC.
次要结局
- To evaluate the safety and tolerability of SCY-078(To evaluate the efficacy of SCY-078 by measuring recurrence of the baseline fungal infection 42 days after EoT (Week 6 Follow up))