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

November 14, 2023 updated by: Scynexis, Inc.

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)

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium
        • Saint Luc University Hospital
      • Ghent, Belgium
        • University Hospital Ghent
      • Leuven, Belgium
        • University Hospitals Leuven, Campus Gasthuisberg
  • Bulgaria
      • Plovdiv, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery
      • Sofia, Bulgaria
        • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery
      • Stara Zagora, Bulgaria
        • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada
        • University Health Network- Toronto General Hospital
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre
  • France
      • Argenteuil, France, 95107
        • Victor Dupouy Hospital Center Argenteuil
      • Nantes, France, 44093
        • Nantes University Hospital Center
      • Paris, France
        • Saint-Louis Hospital
      • Paris, France
        • Paris University Hospitals Center- Cochin Hospital
      • Poitiers, France
        • University Hospital Center of Poitiers
  • Germany
      • Cologne, Germany, 50937
        • University Hospital Cologne
      • Frankfurt, Germany, 60596
        • Frankfurt University Clinic
      • Munich, Germany
        • Municipal Hospital Munich GMbH/Hospital Neuperlach
      • Wuppertal, Germany
        • Helios Clinic Wuppertal
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany
        • University Hospital Freiburg
    • Thuringia
      • Jena, Thuringia, Germany
        • Univeristy Hospital Jena
  • Greece
      • Athens, Greece
        • Laiko General Hospital
      • Athens, Greece
        • General Hospital of Athens "Evangelismos"
      • Athens, Greece
        • General Hospital of Athens "Evangelismos", 1st Department of Critical Care
      • Athens, Greece
        • University General Hospital "Attikon"
      • Thessaloníki, Greece
        • General Hospital of Thessaloniki "Ippokratio"
  • Israel
      • Haifa, Israel
        • Lady Davis Carmel Medical Center, Infectious Diseases Unit
      • Haifa, Israel
        • Rambam Health Care Campus, Institute of Infectious Diseases
      • Tel HaShomer, Israel
        • Chaim Sheba Medical Center
  • Italy
      • Milan, Italy, 20162
        • Big Metropolitan Hospital Niguarda Regional Health Authority
      • Modena, Italy, 41124
        • University Polyclinic Hospital of Modena
      • Udine, Italy
        • Central Friuli University Healthcare Company
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • IRCCS- University Hospital San Martino-IST
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyung University - Dongsan Medical Center
      • Gyeonggi-do, Korea, Republic of
        • CHA Bundang Medical Center, CHA University
      • Seoul, Korea, Republic of
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System
      • Wŏnju, Korea, Republic of
        • Wonju Severance Christian Hospital
  • South Africa
      • Pretoria, South Africa
        • University of Pretoria and Steve Biko Academic Hospital
    • Gauteng
      • Benoni, Gauteng, South Africa, 1500
        • Lakeview Hospital
      • Pretoria, Gauteng, South Africa, 0002
        • Netcare Jakaranda Hospital
      • Pretoria, Gauteng, South Africa, 0002
        • Zuid-Afrikaans Hospital
      • Pretoria, Gauteng, South Africa, 0181
        • Life Groenkloof Hospital
      • Vereeniging, Gauteng, South Africa, 1935
        • FCRN Clinical Trials Centre
    • KwaZulu-Natal
      • Tongaat, KwaZulu-Natal, South Africa, 4400
        • Mediclinic Victoria
  • Spain
      • Madrid, Spain
        • University Hospital de La Princesa
      • Madrid, Spain
        • General University Hospital Gregorio Maranon
      • Madrid, Spain
        • University Hospital Puerta de Hierro Majadahonda
      • Valencia, Spain
        • University and Polytechnic Hospital La fe
      • Valencia, Spain
        • University Clinical Hospital of Valencia
    • Andalusia
      • Seville, Andalusia, Spain
        • University Hospital Virgen Macarena
    • Catalonia
      • Barcelona, Catalonia, Spain
        • Hospital del Mar Medical Research Institute (IMIM)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 70121
        • University of Alabama at Birmingham School of Medicine
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Banner University Medical Center-Tucson
    • California
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical Group, PLLC
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Medicine
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
  • Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).

Key Exclusion Criteria:

  • Subject has any of the following forms of invasive candidiasis at Screening:

    • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
    • Osteomyelitis,
    • Endocarditis or myocarditis,
    • Meningitis, endophthalmitis, or any central nervous system infection,
    • Chronic disseminated candidiasis,
    • Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
    • Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
    • Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
    • Patients who failed a previous antifungal therapy for the same infection,
    • Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
  • Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
  • Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).

  • Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.

    o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.

  • Baseline QTcF ≥ 500 msec.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV echinocandin followed by oral ibrexafungerp (SCY-078)
Drug: SCY-078
Oral ibrexafungerp (SCY-078) as step-down therapy.
Other Names:
  • Ibrexafungerp
Drug: Echinocandin
Intravenous echinocandin
Other Names:
  • Caspofungin
  • Micafungin
  • Anidulafungin
Active Comparator: IV echinocandin followed by oral fluconazole
Drug: Echinocandin
Intravenous echinocandin
Other Names:
  • Caspofungin
  • Micafungin
  • Anidulafungin
Drug: Fluconazole
Oral fluconazole (SCY-078) as step-down therapy.
Other Names:
  • Diflucan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality (US FDA Only)
Time Frame: Day 30
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Day 30
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
Time Frame: Up to 6 weeks
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Response at Day 14
Time Frame: Day 14
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scynexis, Inc.

Investigators

  • Study Director: David Angulo, MD, Scynexis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCY-078-302
  • MSG-20 (Other Identifier: Mycoses Study Group (MSGERC))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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