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Clinical Trials/CTRI/2018/05/013668
CTRI/2018/05/013668
Recruiting
Phase 3

Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SCY 078 in Patients with Candidiasis, Including Candidemia, Caused by Candida auris.

SCYNEXIS Inc0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: null- Patients with Candidiasis, Including Candidemia, Caused by Candida auris

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Patients with Candidiasis, Including Candidemia, Caused by Candida auris
Sponsor
SCYNEXIS Inc
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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