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Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

NCT ID: NCT02244606

Last Updated: 2024-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

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Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)

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

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Detailed Description

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Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Conditions

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Mycoses Candidiasis, Invasive Candidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCY-078 500 mg

A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

SCY-078 750 mg

A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.

Group Type EXPERIMENTAL

SCY-078

Intervention Type DRUG

Standard-of-care

Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

Micafungin

Intervention Type DRUG

Interventions

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SCY-078

Intervention Type DRUG

Fluconazole

Intervention Type DRUG

Micafungin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida.
* Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception.

Exclusion Criteria

* Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis.
* Patient has failed treatment with an echinocandin for this episode of invasive candidiasis.
* Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture.
* Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scynexis, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Angulo, MD

Role: STUDY_DIRECTOR

Scynexis, Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

UC Davis Medical Center

Sacramento, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Georgia Regents University

Augusta, Georgia, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercury Street Medical Group

Butte, Montana, United States

Site Status

Albany Medical Center

Albany, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Dallas VA Medical Center

Dallas, Texas, United States

Site Status

Parkland Hospital

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

South Texas Veterans Healthcare System

San Antonio, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

University of Utah Hospitals and Clinics

Salt Lake City, Utah, United States

Site Status

Hospital Militar Central

San Salvador, , El Salvador

Site Status

Hospital Rosales

San Salvador, , El Salvador

Site Status

University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status

Finca El Palomar

Guatemala City, , Guatemala

Site Status

Hospital Mario Catarino Rivas

San Pedro Sula, Cortés Department, Honduras

Site Status

Instituto Hondureno de Seguridad Social Sucursal San Pedro Sula

San Pedro Sula, Cortés Department, Honduras

Site Status

Countries

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United States El Salvador Germany Guatemala Honduras

Other Identifiers

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SCY-078-202

Identifier Type: -

Identifier Source: org_study_id

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