A phase 3 Study to assess the Effectiveness Safety Tolerability and Pharmacokinetics (what happens to drug in body) of SCY 078 (antifungal drug) in Patients with Candidiasis (Fungal infection) including Candidemia (Fungus in blood ) Caused by Candida auris (Type of fungus)
- Conditions
- Health Condition 1: null- Patients with Candidiasis, Including Candidemia, Caused by Candida auris
- Registration Number
- CTRI/2018/05/013668
- Lead Sponsor
- SCYNEXIS Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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 (�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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>of Treatment (EoT).Timepoint: Efficacy as measured by the percentage of subjects with global success (complete or partial global response) at EoT as determined by the DMC.
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of SCY-078 <br/ ><br>To evaluate the efficacy of SCY-078 by measuring recurrence of the baseline fungal infection 42 days after EoT (Week 6 Follow up) <br/ ><br>To determine the efficacy of SCY-078 by measuring subject survival 42 and 84 days after Day 1 (first dose of study drug)Timepoint: Safety and tolerability as measured by: Physical examination, vital signs, 12-lead electrocardiogram (ECG), safety laboratory <br/ ><br>tests, AEs and treatment discontinuations The percentage of subjects with treatment-emergent AEs