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A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

NCT05178862 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-19

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis included candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole.

Conditions

  • Candidiasis, Invasive
  • Candidemia

Interventions

DRUG

SCY-078

Oral ibrexafungerp (SCY-078) as step-down therapy.

DRUG

Fluconazole

Oral fluconazole (SCY-078) as step-down therapy.

DRUG

Echinocandin

Intravenous echinocandin

Sponsors & Collaborators

  • Scynexis, Inc.

    lead INDUSTRY

Principal Investigators

  • David Angulo, MD · Scynexis, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2025-11-07
Completion
2025-12-16
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • South Africa
  • South Korea
  • Spain

Study Locations

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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 NCT05178862 on ClinicalTrials.gov