MedTrace Logo

Open-Label Study to Evaluate the Efficacy and Safety of Oral Ibrexafungerp (SCY-078) in Patients With Candidiasis Caused by Candida Auris (CARES)

NCT03363841 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-03

Study results available
· View outcomes & findings →

Summary

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.

Conditions

  • Candidiasis, Invasive
  • Candidemia

Interventions

DRUG

SCY-078

Oral SCY-078

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Principal Investigators

  • David Angulo, MD · Scynexis, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-15
Primary Completion
2023-04-14
Completion
2023-05-24
FDA Drug
Yes

Countries

  • United States
  • India
  • Pakistan
  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363841 on ClinicalTrials.gov