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TERMINATED
NCT05178862
PHASE3

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

Sponsor: Scynexis, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2022-08-03

Completion Date

2025-12-16

Last Updated

2026-08-10

Healthy Volunteers

No

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

Locations (101)

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

Banner University Medical Center-Tucson

Tucson, Arizona, United States

UC Davis Medical Center

Sacramento, California, United States

UCSF School of Medicine

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Denver, Colorado, United States

Augusta University Medical Center

Augusta, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

LSU Health Sciences Center

Shreveport, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercury Street Medical Group, PLLC

Butte, Montana, United States

Duke University

Durham, North Carolina, United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

The Miriam Hospital

Providence, Rhode Island, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Saint Luc University Hospital

Brussels, Belgium

University Hospital Ghent

Ghent, Belgium

University Hospitals Leuven, Campus Gasthuisberg

Leuven, Belgium

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery

Plovdiv, Bulgaria

University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"

Stara Zagora, Bulgaria

Princess Margaret Hospital

Toronto, Ontario, Canada

University Health Network- Toronto General Hospital

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

The First Affiliated Hospital of Guangzhou Medical University

Guandong, Guangzhou, China

The First Affiliated Hospital of Jinan University

Guandong, Guangzhou, China

Nanfang Hospital of Southern Medical University

Guangdong, Guangzhou, China

The Third Affiliated Hospital Of Sun Yat-Sen University (ZSSY)

Guangdong, Guangzhou, China

Hainan General Hospital

Haikou, Hainan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

Liuzhou People's Hospital

Liuzhou, Liuzhou, China

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Huashan Hospital, Institute of Antibiotics

Shanghai, Shanghai Municipality, China

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Chinese Academy of Medical Sciences

Jinghai, Tianjin Municipality, China

Tianjin Medical University General Hospital

Xiaobailou, Tianjin Municipality, China

The First Hospital of Kunming

Kunming, Yunnan, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Yuzhong, China

The first affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Provincal Hospital of Chinese Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Lishui People's Hospital

Lishui, Zhejiang, China

Victor Dupouy Hospital Center Argenteuil

Argenteuil, France

Nantes University Hospital Center

Nantes, France

Paris University Hospitals Center- Cochin Hospital

Paris, France

Saint-Louis Hospital

Paris, France

University Hospital Center of Poitiers

Poitiers, France

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Univeristy Hospital Jena

Jena, Thuringia, Germany

University Hospital Cologne

Cologne, Germany

Frankfurt University Clinic

Frankfurt, Germany

Municipal Hospital Munich GMbH/Hospital Neuperlach

Munich, Germany

Helios Clinic Wuppertal

Wuppertal, Germany

General Hospital of Athens "Evangelismos", 1st Department of Critical Care

Athens, Greece

General Hospital of Athens "Evangelismos"

Athens, Greece

LAIKO General Hospital

Athens, Greece

University General Hospital "Attikon"

Athens, Greece

General Hospital of Thessaloniki "Ippokratio"

Thessaloniki, Greece

Lady Davis Carmel Medical Center, Infectious Diseases Unit

Haifa, Israel

Rambam Health Care Campus, Institute of Infectious Diseases

Haifa, Israel

The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Chaim Sheba Medical Center

Tel Litwinsky, Israel

IRCCS- University Hospital San Martino-IST

Genoa, Liguria, Italy

Big Metropolitan Hospital Niguarda Regional Health Authority

Milan, Italy

University Polyclinic Hospital of Modena

Modena, Italy

Central Friuli University Healthcare Company

Udine, Italy

Lakeview Hospital

Benoni, Gauteng, South Africa

Netcare Jakaranda Hospital

Pretoria, Gauteng, South Africa

Zuid-Afrikaans Hospital

Pretoria, Gauteng, South Africa

Life Groenkloof Hospital

Pretoria, Gauteng, South Africa

FCRN Clinical Trials Centre

Vereeniging, Gauteng, South Africa

Mediclinic Victoria

Tongaat, KwaZulu-Natal, South Africa

University of Pretoria and Steve Biko Academic Hospital

Pretoria, South Africa

Keimyung University - Dongsan Medical Center

Daegu, South Korea

CHA Bundang Medical Center, CHA University

Gyeonggi-do, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Wonju Severance Christian Hospital

Wŏnju, South Korea

University Hospital Virgen Macarena

Seville, Andalusia, Spain

Hospital Clínic de Barcelona

Barcelona, Catalonia, Spain

Hospital del Mar Medical Research Institute (IMIM)

Barcelona, Catalonia, Spain

University Hospital Ramon y Cajal

Madrid, Spain

General University Hospital Gregorio Maranon

Madrid, Spain

University Hospital de La Princesa

Madrid, Spain

University Hospital Puerta de Hierro Majadahonda

Madrid, Spain

University and Polytechnic Hospital La Fe

Valencia, Spain

University Clinical Hospital of Valencia

Valencia, Spain